244 Medical Diagnostics jobs in the United States
Director, Project Management, Medical Devices & Diagnostics
Posted 2 days ago
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Director, Project Management, Medical Devices & Diagnostics Country United States Shift 1st About the Position Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary The Director, PMO will report directly into the COO, will serve as a member of the Executive Management team and will be responsible for leading and managing the project management function for the Autoimmunity division. This individual has oversight of product related projects within the business. Ensures effective project management methodology is deployed and used throughout the business for product development and life-cycle management (on-market). Monitors project performance and ensures that all key projects are being executed to Scope, on time and within budget.Identifies both trends in project management practices and risks in specific projects that need to be resolved. Coordinates with the functional managers and executives to ensure resource are allocated in the best manner to optimized business and project results. Collaborates with other Werfen entities on best practices of project management. Works to continiuously increase the maturity level of the PMO towards a strategic project management office (sPMO). Ensures all work is carried out in accordance with Autoimmunity’s Quality Management System as well as all of administrative and regulatory requirements. Participates in business strategic planning, representing current and planned projects needed to implement the business strategy. Provides direct and/or indirect supervision to members of the management team and/or members of the PMO. Position requires strong, cross-functional leadership skills in a highly technical medical device product development environment. Responsibilities Key Accountabilities Technical and Program Leadership: Provide general oversight and leadership to all product development projects. Responsible to assign project managers to all product development projets and other strategic project as defined by the senior management team. Project Management Process: Establishes, defines and maintains the project management system and processes. Provides direction to the Project Sponsor with respect to the project scope, objectives, deliverables and measurements for the product development project management methodology. Works with project managers to define project team composition, meeting structure and caidance. Conduct regular reviews of the program / project portfolio of all product development projects to ensure business objectives will be met. Work with the Project Sponsors to continually improve the product development project management methodology. Program Planning, Execution and Control: Periodically review project plans (scope, timeline and budget) and status to ensure the application of best practices for project management and the efficacy of the product development project management methodology. Periodically review the status of the portfolio of development projects and programs with other members of the senior management team. Strategy Development: Participates with senior management in mid- to long-term strategy related to new areas of scientific and technological research and development. Originates major new ideas for company projects and programs. Risk Management: Oversees project risk management from project planning to completion. This includes but is not limited to baseline risk analysis and mitigation. Periodically review project risk drivers and actions to identify trends. Implement organizational and process changes to reduce overall project risk. Design Control: Oversees the creation and maitainance of all elements required for Design Control procedure. This includes management according to our design control procedure using a phase gate approach. Business Management: As a member of the business management team, provide plans and status updates concerning product development and life-cycle management projects that support the business. Participate with other senior management team to make the best use of resources among the competing business needs. Ensures that an adequate pool of equipment and resources are available to meet the needs of the projects within the business constraints. Prepares and manages department budgets. Communication: Regularly interacts with senior management, customers and regulatory agencies concerning program status and strategic planning. Supervision and Employee Performance: Leads and manages the PMO team, including people managers and individual contributors. Responsible for hiring and developing a high performance team. Role models Werfen Values and ensures compliance with company policies. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key R elationships Research & development teams (both) Clinical Software team Quality & Regulatory teams Manufacturing teams Other Autoimmunity and Werfen departments and staff Qualifications M in imum Knowledge & Experience for the position: BS Degree, MS/MBA preferred, in a technical or management discipline PMP certification is preferred additional course work in accounting, business economics, resource management and project management is desired. Requires full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing in IVD insustry Fifteen years product development experience, including eight years in successful technical leadership, project coordination, or project management are required. Experience in the development and release of at least one successful product launch of a medical device product is required. Skills & Capabilities: Business Acumen; Technical Skills; Process Management; Strong organization and planning skills Strong oral and written communication skills Stakeholder management and Leading in a matrix The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility. The salary range for this position is currently $150,000- $25,000. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 b llion and more than 7,000 employees around the world comprise our Werfen team. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. #J-18808-Ljbffr
Medical Technologist, Molecular Diagnostics
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Medical Technologist, Molecular Diagnostics Join to apply for the Medical Technologist, Molecular Diagnostics role at University Hospital . The primary purpose of this position is to perform routine and complex laboratory analyses. The role involves responsibility for procedural and system controls, problem solving, teaching, and supervision under direction independently. Provides physicians with accurate and reliable analytical results necessary for the diagnosis and treatment of patients. Qualifications: Bachelor’s Degree in Medical Technology or a related field. ASCP certification or equivalent is preferred. Certification in molecular biology/molecular diagnostics is preferred. University Hospital offers a competitive salary & comprehensive benefits package. Affirmative Action/Equal Opportunity Employer, M/F/D/V. For more information, visit . Additional Details: Seniority level: Entry level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Hospitals and Health Care This job posting appears active and does not contain any indications of being expired. #J-18808-Ljbffr
Validation Lead - Clinical Diagnostics
Posted 24 days ago
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Are you interested in working with the World’s leading AI-powered Quality Engineering Company? Ready to advance your career, team up with global thought leaders across industries and make a difference every day? Join us at Qualitest! We are looking for a Validation Lead - Clinical Diagnostics to join our growing team in Concord, California! Role - Validation Lead - Clinical Diagnostics Location - Concord, CA (on-site) As a Senior Validation Engineer within Global Systems Engineering Organization, you’ll be right at the forefront of Clinical Diagnostics R&D Group – leading the design validation of clinical diagnostics products across immunology, immunohematology, diabetes, infectious diseases and women’s reproductive health applications. You will leverage your clinical domain experience, quality mindset and analytical skills to own design validation deliverables such as plans, protocols, test execution, issues investigations and results reports for assigned projects. You will assess products conformity to user needs, intended use and use environments and support new products launch decision with clear and traceable objective evidence. You will bring customer centricity to development teams, influence them to integrate our user’s perspective in their design and testing, help them to focus on delivering a best-in-class experience and quality for our customers. You will bring multi-disciplinary teams of clinical, human factors, R&D, marking and sales specialists together to face users and gather their feedback on design artifacts with various maturity. How You’ll Make An Impact Leverage extensive clinical laboratory domain experience and strong relationships to adequately represent Bio-Rad products users’ perspectives. Train design teams to have a deeper understanding of clinical practices and set up representative use environments, laboratory workflows and routine practices. Champion the adopt on and execution of customer centricity principles. Lead the planning, design, coordination and execution of design validation studies in collaboration with clinical affairs, human factors, R&D, marketing and sales specialists to gather user feedback at various stages of product design. Manage external vendors or test labs involved in validation testing as needed, execute well coordinated internal and external testing. Generate traceable and comprehensive objective evidence and documentation for design validation including plans, protocols, issues and reports supporting regulatory submissions strategies. Analyze test results, identify and resolve complex user related and technical issues, identify areas for improvement and guide the product development team to prioritize feedback and improvements. Leverage a global organization talent pool to optimize design validation testing activities quality, cost & duration. Drive risk-based validation approaches, ensuring alignment with product risk classification and intended use environments. Communicate technical information clearly and concisely to both technical and non-technical audiences. What You Bring Education: MSc or Ph.D in Biomedical Engineering, Medical Biology or equivalent. Work Experience 8+ years’ experience in Design Validation for new In vitro diagnostics (IVD) or medical device (MD) products. Demonstrated a leading role in planning, execution and reporting of design control validation studies in R&D, clinical and human factors context. 3+ years’ functional or project management experience. Successful track record of bringing together and focus diverse teams, including customers, to lunch quality products. 2+ years’ hands on work in a clinical diagnostics or hospital environment. Successful track record of establishing and maintaining relationships with our customers. Excellent listening, communication, and social skills with a user / customer centric mindset. Field experience is desirable. Excellent observation, analytical, and critical thinking skills with data science fluency. Proficiency with Python, or Matlab preferred. Ability to work and excel within a global, fast paced, and cross-functional work environment with a continuous learning mindset. LEAN Green Belt or Black Belt certification is desirable. Why QualiTest? Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences. Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career. Clear view of your career and progression with the company – Qualitest is growing massively and giving you the opportunity to grow with us. Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers. Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan. Take care of health with enrollment into one of our competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate. Never stop experimenting and learning with Qualitest Tech academy: 3000+ training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs and much more Stay active and get rewarded with our Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym! Salary of $100-105k anually. Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth. Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless! Intrigued to find more about us? Visit our website at Careers - Qualitest Group If you like what you have read, send us your resume and let’s start talking! #J-18808-Ljbffr
Sr. Associate - MLS - Clinical Diagnostics Laboratory
Posted 1 day ago
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**Eli Lilly Clinical Diagnostics Laboratory**
**Medical Laboratory Scientist**
**Job Description**
**Purpose of the Job:**
The Eli Lilly Clinical Diagnostics Laboratory (ELCDL) supports pre-screening, clinical trial, and assay development activities, as well as diagnostic testing to aid in the diagnosis and treatment of patients. Testing personnel in the ELCDL develop, validate, implement, and perform testing to support the overall business strategy and corporate portfolio objectives. These clinical tests may be used in clinical research or as Laboratory Developed Tests (LDT) but might also include In Vitro Diagnostics (IVD) approved by regulatory bodies. Data generated might also be utilized to support regulatory submissions.
The Medical Laboratory Scientist (MLS) or Medical Technologist (MT) role in the ELCDL is responsible for specimen handling (validation, triaging, storage) and analysis of human biological samples using different types of laboratory testing, while operating under the CAP/CLIA quality system and other regulatory standards, as appropriate.
**Key Responsibilities of Job:**
Pre-Analytical:
+ Determine the acceptability of specimens for testing according to established criteria.
+ Manage specimens and test orders in Laboratory Information System (LIS)/ Laboratory Information Management System (LIMS).
+ As part of a client service team, act as single point of contact for testing status and communication with customers.
+ Provide consultation to clients including assistance with ordering, shipping, and sample questions or turnaround time expectations.
+ Work with lab business partners to ensure the client accounts are set-up in compliance with testing and quality requirements while maintaining the confidentiality of health information on all patients.
Analytical:
+ Understand the basic nature of ELCDL assays and their technical process.
+ Skillfully perform routine and sophisticated technical procedures according to Standard Operating Procedures (SOP).
+ Produces and documents accurate laboratory results which may be subject to regulatory review.
+ Monitor, operate and troubleshoot instrumentation to ensure functionality.
+ Prepare, test and evaluate new reagents or controls.
+ Demonstrate the ability to make technical decisions regarding testing and problem solving.
+ Performs only those high complexity tests authorized by the laboratory director.
Post Analytical:
+ Report accurate and on time test results.
+ Manage clinical lab data and generate reports.
+ Maintains the confidentiality of health information on all patients.
+ Ensure timely communication to client on matters related to availability of test results or issues with specimens during receipt or testing.
General:
+ Must follow laboratory procedures.
+ Demonstrate proficiency and competency.
+ Document all corrective actions when testing deviates from lab established performance specifications.
+ Identify and replenish testing bench supplies as required.
+ Perform and document preventive maintenance and quality control procedures.
+ Maintenance and QC of laboratory reagents and equipment.
+ Maintain inventories of reagents and lab supplies.
+ Maintain a safe work environment and wear appropriate personal protective equipment.
+ Other duties and projects as assigned.
+ Performs well in a team, open to sharing and receiving knowledge and skills, as required.
Application of regulatory requirements:
+ With supervision, responsible for understanding and applying regulations as they relate to analytical method development, validation, and execution.
+ Conduct and document all laboratory procedures according to appropriate regulations.
+ Exhibit behavior that supports and promotes all appropriate Lilly and regulatory procedures and CAP/CLIA guidelines.
+ Effectively apply specialized diagnostics knowledge and in depth understanding of applicable internal, external, and regulatory requirements/expectations (MQA, CSQ, FDA, ICH, Privacy, Diagnostics, CLIA) for management of samples.
Technical process application and improvement:
+ Develop and apply expertise and knowledge of instrument operation and theory.
**Minimum Qualification Requirements:**
+ ASCP/AMT certified
+ MT/MLS certified
+ Bachelor's degree in a Core Science or Statistics related degree from an accredited institution
+ 1+ years of laboratory experience
+ Meet one of the CLIA requirements for high complexity testing personnel under 42 CFR 493.1489 ( .
+ Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
**Additional Skills/Preferences:**
+ Ability to inspire change and implement process improvement.
+ Ability to thrive in grey space and have a solid understanding of testing and quality principles--not just the written guidance.
+ Strong interpersonal and team related skills required.
+ Experience with various assay platforms and computer software applications including LIS systems.
+ Bench level experience in Immunoassay and Molecular preferred.
+ Experience in data analysis or statistics and associated tools preferred.
+ Knowledgeable in CAP/CLIA and CLSI guidelines.
+ Knowledge of homebrew assays and Laboratory Developed Tests is helpful.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $155,100
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Medical Technologist PD, Molecular Diagnostics
Posted today
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Responsibilities The primary purpose of the Medical Technologist Molecular Diagnostics position is to perform routine and complex laboratory analyses; assumes responsibility for procedural and system controls, problem solving, teaching and supervision under direction independently. Provides physicians with accurate and reliable analytical results necessary for the diagnosis/treatment of patients. Qualifications Bachelor’s Degree in Medical Technology or a related field. ASCP certification or equivalent is preferred. Certification in molecular biology/molecular diagnostics is preferred. #J-18808-Ljbffr
Medical Technologist - Molecular Diagnostics/Cytogenetics - Full Time - AGH
Posted today
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Allegheny Health NetworkJob Description :
GENERAL OVERVIEW:
This job independently performs routine and highly complex laboratory analyses on clinical specimens in one or more sections of the laboratory.
ESSENTIAL RESPONSIBILITIES:
- Performs a variety of routine and complex procedures using established criteria to provide quality clinical information. Verifies analytic accuracy, precision, sensitivity, and linearity for test methods. (40%)
- Operates, calibrates, checks, and maintains instrumentation. Recognizes problems with quality control and test procedures and takes appropriate action to ensure quality clinical information. (30%)
- Provides oversight and mentors ALT, MLT, phlebotomist, students, and new employees in laboratory testing following system policies and procedures, as well as any applicable State regulations, to ensure accuracy and quality (20%)
- Serves as a consultant to medical laboratory technicians, phlebotomists, other health care providers, as needed. Participates in continuing education to ensure growth and development of the laboratory. (5%)
- May collect and process patient specimens in accordance with laboratory policies and procedures and within the expected time frames. (5%)
- Performs other duties as assigned or required.
Minimum
- Bachelor's degree in ASCP eligible program
- If located in Pennsylvania: MLS, MT, Categorical or Specialty ASCP Certification, required within 1 year of hire. Incumbents in role as of June 1, 2022 are exempt from this expectation.
- If located in New York: Clinical Laboratory Technologist
- 1 to 2 year's clinical laboratory experience
Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.
Compliance Requirement : This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies.
As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company's Handbook of Privacy Policies and Practices and Information Security Policy.
Furthermore, it is every employee's responsibility to comply with the company's Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.
Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law.
We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact the email below.
For accommodation requests, please contact HR Services Online at
California Consumer Privacy Act Employees, Contractors, and Applicants Notice
Medical Technologist - Molecular Diagnostics/Cytogenetics - Full Time - AGH
Posted 12 days ago
Job Viewed
Job Description
Allegheny Health Network
**Job Description :**
**GENERAL OVERVIEW:**
This job independently performs routine and highly complex laboratory analyses on clinical specimens in one or more sections of the laboratory.
**ESSENTIAL RESPONSIBILITIES:**
+ Performs a variety of routine and complex procedures using established criteria to provide quality clinical information. Verifies analytic accuracy, precision, sensitivity, and linearity for test methods. (40%)
+ Operates, calibrates, checks, and maintains instrumentation. Recognizes problems with quality control and test procedures and takes appropriate action to ensure quality clinical information. (30%)
+ Provides oversight and mentors ALT, MLT, phlebotomist, students, and new employees in laboratory testing following system policies and procedures, as well as any applicable State regulations, to ensure accuracy and quality (20%)
+ Serves as a consultant to medical laboratory technicians, phlebotomists, other health care providers, as needed. Participates in continuing education to ensure growth and development of the laboratory. (5%)
+ May collect and process patient specimens in accordance with laboratory policies and procedures and within the expected time frames. (5%)
+ Performs other duties as assigned or required.
**QUALIFICATIONS:**
**Minimum**
+ Bachelor's degree in ASCP eligible program
+ If located in Pennsylvania: MLS, MT, Categorical or Specialty ASCP Certification, required within 1 year of hire. Incumbents in role as of June 1, 2022 are exempt from this expectation.
+ If located in New York: Clinical Laboratory Technologist
**Preferred**
+ 1 to 2 year's clinical laboratory experience
**_Disclaimer:_** _The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job._
**_Compliance Requirement_** _: This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies._
_As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company's Handbook of Privacy Policies and Practices and Information Security Policy._
_Furthermore, it is every employee's responsibility to comply with the company's Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements._
Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law.
We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact the email below.
For accommodation requests, please contact HR Services Online at
California Consumer Privacy Act Employees, Contractors, and Applicants Notice
Req ID: J262845
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Quality Assurance in Veterinary Diagnostics/Medical Devices || Onsite Role
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Join to apply for the Quality Assurance in Veterinary Diagnostics/Medical Devices | Onsite Role role at AppLab Systems, Inc
Quality Assurance in Veterinary Diagnostics/Medical Devices | Onsite Role1 month ago Be among the first 25 applicants
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Title : Quality Assurance in Veterinary Diagnostics
Location : Denver, Colorado | Onsite role
Mode : Contract | Long Term
Job Description:-
Quality Assurance In Veterinary Diagnostics
- Design and execute test plans, test cases, and test scripts for veterinary diagnostic devices (e.g., analyzers from IDEXX, Abaxis, Heska).
- Validate data flow between instruments, middleware, LIS systems, and cloud-based analytics.
- Conduct functional, regression, integration, system, and UAT testing across chemistry, hematology, and pathology workflows.
- Test end-to-end scenarios involving Azure Cloud services (IoT Hub, Data Factory, Event Grid, Azure SQL) and OEM edge/on-prem devices.
- Validate telemetry, data streaming, buffering, and processing pipelines in cloud-device integration.
- Perform interface testing between device firmware, APIs, and Azure-hosted applications and dashboards.
- Develop automated test scripts for device simulators, API endpoints, and cloud data ingestion using tools such as Selenium, Postman, JMeter, or Azure Load Testing.
- Collaborate with DevOps for CI/CD testing workflows using Azure DevOps, GitHub Actions, or Jenkins.
- Ensure traceability of test cases to requirements and risk controls (FDA 21 CFR Part 820, ISO 13485, ISO 14971, GDPR).
- Prepare precise and audit-ready reports detailing test coverage, pass/fail rates, defect metrics, and release readiness.
- Perform root cause analysis of issues related to data integrity, latency, device communication, and user interface discrepancies.
- Bachelor's or Master's in Life Sciences, Biomedical Engineering, Computer Science, or related discipline.
- 8+ years of QA experience in medical or veterinary diagnostic devices (chemistry, hematology, pathology).
- Strong understanding of OEM device interfaces, communication protocols (HL7, ASTM, POCT1-A, TCP/IP, RS232).
- Proficient in Azure Cloud services (Data Factory, IoT Hub, Monitor, SQL, Key Vault).
- Strong command of test documentation, bug tracking systems (JIRA, Azure DevOps), and reporting tools (Power BI, Excel, SQL).
- Experience with cybersecurity, data validation, and regulatory compliance testing (FDA, ISO, GDPR).
Saurav Kumar
APPLAB Systems
Ext - 551
4365 Route 1 South, Suite 105
Princeton, NJ -08540
Seniority level
- Seniority level Entry level
- Employment type Full-time
- Job function Quality Assurance
- Industries Staffing and Recruiting
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#J-18808-LjbffrMedical Laboratory Scientist - Molecular Diagnostics - 40 hrs - Variable
Posted 5 days ago
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Medical Laboratory Scientists in Molecular Diagnostics play a critical role in advanced genetic testing, specializing in DNA/RNA isolation, RT-PCR, qPCR, and Next-Generation Sequencing (NGS). Their work involves a balance of automated and manual benchwork and pipetting, and pre/post analytical tasks, such as writing SOPs, maintaining CAP, ISO15189 and CLIA regulatory compliance, and result reporting in the LIS. MLS professionals frequently collaborate with directors and pathologists for reporting, ensuring accuracy in diagnostics. Operating in an ever-evolving environment, the team continuously integrates new advancements and follows LEAN laboratory principles for process optimization and problem-solving.
GENERAL SUMMARY:
Under general supervision, performs routine and complex analytic procedures on blood and/or other body fluids or specimens, involving manual techniques or the use of laboratory instruments and information systems.
PRINCIPLE DUTIES AND RESPONSIBILITIES:
- Performs routine and complex biological, chemical, cytological, hematological, histologic, immunological, microscopic, and/or bacteriological tests procedures on laboratory specimens, using manual or automated techniques and information systems, for the purpose of diagnosing, preventing, or treatment of disease.
- The Medical Technologist is qualified to perform all duties of the Medical Technologist job, and in a given job situation may or may not perform all of the duties; actual duties will pertain to the specific Medical Technologist position.
- Applies knowledge, training, and independent clinical judgment to take action and/or develop solutions.
- Collaborates with leadership staff to improve processes and resolve problems, including: Evaluating instrument performance and quality control results to ensure the accuracy and reliability of all analytic data prior to release; Correlating results with other lab data and/or disease states; Identification of technical, instrument, pharmacologic and/or physiologic causes of unexpected test results.
- Performs calibration, preventive maintenance, quality control, and troubleshooting of laboratory equipment, instruments and/or laboratory information systems.
EDUCATION/EXPERIENCE REQUIRED:
1. Minimum of a bachelor's degree from an accredited college or university required. Coursework must align with duties of the specific section Medical Laboratory discipline position and meet the education Eligibility Routes for Medical Laboratory Scientist listed on the ASCP website at (ascp.org); or possesses a categorical scientist level certification as a BB, C, CG, CT, M, MB; or has met the requirements for AAB and/or AMT certifications.
2. Requires six months of experience in a medical laboratory setting.
3. Demonstrated technical proficiency and theoretical knowledge sufficient to perform laboratory functions are required.
CERTIFICATIONS/LICENSURES:
Certification at the technologist, or medical/clinical lab scientist level from a nationally recognized agency, such as ASCP, AMT, ASM, AAB, AABB, ACS, or HEW is preferred.
Clinical Laboratory & Diagnostics Specialist ( 2nd shift )
Posted 1 day ago
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Job Description
Payrate: $30-32/hour
Duration: 1-year contract (Excellent potential for permanent)
Hours: Full-time | Monday-Friday | 3pm-11:30pm
Start Date: ASAP
Location: Irvine, CA 92618 (Onsite - Local candidates only)
Summary:
Ready to be part of a global mission to help people live longer, healthier lives? Join a world-class team of innovators, leaders, and problem solvers who develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities worldwide. As a Clinical Laboratory & Diagnostics Specialist on our 2nd shift team, you'll play a crucial role in supporting finished product testing and release of company controls. Working in our Quality Control department, you'll combine technical expertise with collaborative teamwork to ensure the highest standards in clinical diagnostic testing. If you're passionate about precision, thrive in a fast-paced lab environment, and want to make a real impact on global healthcare, this is your opportunity to shine.
What You'll Do:
- Operate, maintain, calibrate, and troubleshoot clinical diagnostic laboratory instruments with precision and expertise
- Follow good laboratory practices (GLP) and good documentation practices (GDP) to ensure compliance and quality
- Work collaboratively with team members to achieve daily testing goals and objectives
- Evaluate assay runs for accuracy and acceptability according to Quality Control procedures
- Enter results into appropriate software and database systems with attention to detail
- Order supplies required for testing on assigned instrumentation to maintain seamless operations
- Support finished product testing and release of company controls during 2nd shift operations
- Perform daily maintenance and troubleshooting on clinical diagnostic instrumentation
- Associate's degree or higher in science field or equivalent clinical lab experience
- 2+ years of experience in clinical laboratory and diagnostics setting
- Experience performing daily maintenance of instrumentation or relevant school experience
- Familiarity with clinical laboratory instruments from manufacturers like Beckman, Roche, Siemens, or Abbott
- Ability to operate, maintain, calibrate, and troubleshoot clinical diagnostic lab instruments
- Excellent multitasking and organizational skills in fast-paced environments
- Basic knowledge of Microsoft Excel, Outlook, and Word
- Strong attention to detail and commitment to quality standards
- Experience running chemistry/immunoassay/immunology analyzers and/or ELISAs
- Knowledge of LIMS (Laboratory Information Management System)
- Advanced certifications in clinical laboratory technology
- Experience with regulatory compliance in clinical settings
- Background in quality control or quality assurance processes
Make a meaningful impact on global healthcare while advancing your career in a cutting-edge laboratory environment. With competitive hourly pay, weekly pay, and comprehensive benefits, plus excellent potential for permanent placement, you'll have the foundation to excel in this vital role. Apply now to become our next Clinical Laboratory & Diagnostics Specialist and help us continue our mission of improving lives worldwide.
TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.
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