2,316 Principal Tester jobs in the United States

Summary of Job Responsibilities

The Software Quality Assurance (QA) Engineer ensures high-quality software delivery by planning, implementing, and automating quality assurance testing. Responsibilities include developing test plans, creating test cases, writing test automation code, and reporting results.

Ideal Candidate Statement

We are on the lookout for a detail-oriented Software Quality Assurance (QA) Engineer to join our team. The ideal candidate will be an analytical thinker and have a keen eye for detail. Experience implementing automated testing across the entire development stack is desirable, including front-end, server side, and end-to-end testing. The candidate should enjoy working as part of a close-knit team to ensure software products meet the highest standards of quality, usability, and reliability.

Essential Duties and Responsibilities

Employees are held accountable for all duties of the job. Individuals must be able to perform these duties with or without reasonable accommodations.

• Plan and implement testing (e.g., regression, functional, data validation, system integration, load, or performance tests) for new and existing functionality

• Work closely with development teams, including participation in product design, to plan testing strategies and integrate testing into the development process

• Plan, create, execute, and automate test cases, working with business partners, developers, and other stakeholders

• Document and analyze test results, recommend corrective action, and communicate steps to reproduce behavior

• Isolate, reproduce, manage, and maintain defects and test case databases, and verify fixes

• Support user acceptance testing conducted by business partners or end users

• Conduct exploratory testing and risk analysis for complex features, e.g., those that span across platforms or teams

• Identify opportunities to reduce testing time and effort by automating repeatable tests

• Enhance and maintain the test automation framework

• Understand and apply automated testing approaches such as model-based testing or record-and-replay

• Research, recommend, and implement new testing technologies and practices, such as incorporating machine learning. Define and champion quality and testing best practices among development teams

• Collaborate and share information with developers and other software QA engineers

• Understand product requirements and review test plans to ensure comprehensive coverage

• Performs other duties as assigned

Job Qualifications

• Bachelor’s degree in Computer Science or related field or equivalent combination of education and experience

• 3+ years of quality assurance testing experience

• Software development experience. Proficiency in Java and JavaScript

• Experience writing test automation scripts

• Experience with SQL

• Experience designing and implementing test plans

• Experience with test management tools (e.g., TestRail, XRay, Qtest, Quality Center)

• Experience with test automation frameworks (Selenium, Postman, Karma, Katalon, Cypress, Puppeteer, etc)

• Experience with application performance monitoring and observability tools

• Attention to detail and ability to identify, isolate and document defects

• Strong knowledge of agile practices and experience with agile planning tools (e.g., Jira)

• Effective verbal and written communication skills for both technical and non-technical audiences

• Collaboration skills and ability to work on a team

• Adaptability and willingness to learn

• Background in financial services or insurance industry preferred

Working Conditions

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.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Standard office environment with frequent telephone communication, computer operation, and other office productivity machinery, such as a copy and printer machine.

• Occasional moving and positioning supplies in excess of 20 pounds

• All employees are expected to present themselves in a professional manner in alignment with the financial services industry

• Ability to sit for prolonged periods of time

• Ability to operate standard PC equipment

• Ability to handle stress associated with frequent deadline and tight schedules

Hybrid Work Option

• Opportunity to work from home up to three days per week. Eligibility dependent upon factors detailed in PERA's Work from Home Policy.

We need a Software Quality Assurance (QA) Engineer for a 6+ month contract role at our Healthcare client in Los Angeles, CA .

This is a REMOTE position, but we would need candidates who are in Southern CA . Need to have Healthcare background.
International Software Testing Qualifications Board (ISTQB) Certification

Job Summary
Reporting to the Quality Assurance (QA) Manager, Information Technology (IT) Quality Management, the Software Quality Assurance Engineer II will perform test planning, manual test case authoring, scripting automated scripts, test execution, review test activities, test reporting on assigned tasks and deliverables of QA consultants. The Software Quality Assurance Engineer II plays a major role to improve the quality, functionality, reliability and usability of software products. The Software Quality Assurance Engineer II is responsible to review the business requirements and create test plans, test cases, automated scripts, execute tests according to policy, guidelines, SQA industry best practices and escalate as appropriate. The Software Quality Assurance Engineer II will need to stay abreast on the latest industry test tools, test approaches, Information Technology skills, systems, application and technologies to proactively and continually contribute to improving the quality of systems. Adhere to test management best practices including requirements gathering, test case creation, test case execution, defect management, metrics and reporting. The Software Quality Assurance Engineer II will contribute to building, enhancing and maintaining the Continuous Testing Framework.
Duties
Review business requirements, system documentation and project assets to create robust, accurate, usable test artifacts (test plans, test cases, automated scripts, reports) to ensure end results aligns with business needs. Analyze requirements and effectively apply appropriate testing techniques to ensure comprehensive testing coverage in a timely manner. Create or assist in creating, socializing and presenting test approach, test artifacts, testing process, test metrics with appropriate teams. Prepare test data and ensures readiness of test environment prior to test execution. Ensure adherence to software quality criteria, policy, guidelines and industry best practices. Promptly and effectively escalates issues as appropriate. Proactively engages with development teams and project team members to help promote prevention of defects early in project/development lifecycle. Participate in and/or lead test case reviews, user stories, risk assessments, requirement reviews, sprint reviews, backlog grooming sessions and retrospectives. Execute tests (manual and test automation) to validate expected results. Publishes and socializes testing results and metrics to enable business decisions and promote continuous improvement. Identify and appropriately escalates non-standard results and other quality issues. Effectively logs defects and quality concerns using test management systems and any other reporting systems per policy and guidelines. Help drive the adoption and consistent usage of industry standard quality best practices, testing methodologies and the maturity of the Continuous Testing Framework.
Education Required
Bachelor's Degree in Computer Science or Management Information Systems. In lieu of degree, equivalent education and/or experience may be considered.
Education Preferred
Master's Degree in Computer Science or Management Information Systems
Experience
Required:
At least 5 years as a Software Quality Assurance Engineer role including functional and non-functional testing activities. Experience participating in the review of business requirements to develop test strategy, deploy risk-based testing tactics, writing test plans and test cases. Experience as an Author of automated scripts according to Software Quality Assurance industry test automation best practices. Experience executing manual test cases and automated scripts to detect and report defects. Experience effectively communicating quality related matters across an organization and project teams. Experience participating in DevOps initiatives to shift-left in testing approach. Experience collaborating in blended teams with onsite, nearshore and offshore project resources.
Preferred:
1 to 2 years collaborating in blended teams with onsite, nearshore and offshore project resources. Experience defining processes and procedures for all automated platform and application testing including the development and maintenance of automated scripts. Experience executing automation testing including tests using open source tools such as Cucumber, JUNIT, Jenkins, Selenium . Experience working with stakeholders and Business Systems Analysts to refine business requirements.
Skills
Required :
Solid understanding of the Software Development Life Cycle, Agile methodologies, and Waterfall methodologies. Working knowledge of health domains such as Member portals, Provider portals, Healthcare Finance, Health Services, and Claims.
Black-box testing capabilities.
Backend testing capabilities using SQL. Test Automation capabilities.
Preferred:
Hands-on testing experience on healthcare systems such as QNXT, Facets, Syntranet or equivalent. Familiarity of EDI transactions (834, 835, 837) for organizations and trading partners to electronically communicate.
Performance testing, Security testing, Mobile testing. Understanding of programming concepts and skills such as Python, Java, C, C++, R JavaScript, Matlab DevOps, CI/CD

• Lead and execute comprehensive application penetration tests across a wide range of technologies, including web applications, mobile applications (iOS/Android), APIs, and cloud platforms (AWS, Azure, GCP).
• Identify and exploit security vulnerabilities such as SQL injection, cross-site scripting (XSS), authentication bypass, authorization flaws, and insecure direct object references (IDOR).
• Conduct thorough code reviews and analyze application logic to uncover security weaknesses.
• Develop and maintain custom tools, scripts, and techniques to automate security testing and enhance penetration testing capabilities.
• Document findings clearly and concisely in detailed reports, including risk assessment, vulnerability impact, and actionable remediation recommendations.
• Present penetration test results and strategic insights to technical teams, management, and business stakeholders.
• Collaborate with development and operations teams to foster a secure-by-design approach and support the remediation process.
• Stay current with the latest application security threats, vulnerabilities, and penetration testing methodologies.
• Mentor and guide junior penetration testers, sharing knowledge and best practices.
• Contribute to the development and refinement of the organization's offensive security program and playbooks.
• Participate in security architecture reviews and provide input on secure coding practices.
• Maintain strict confidentiality regarding all test findings and organizational information.

• Bachelor's degree in Computer Science, Cybersecurity, or a related field.
• Minimum of 8 years of experience in offensive security, with a strong focus on application penetration testing.
• Deep understanding of OWASP Top 10 vulnerabilities, common attack vectors, and exploit techniques.
• Proven experience with various penetration testing tools (e.g., Burp Suite, OWASP ZAP, Nessus, Metasploit).
• Proficiency in scripting languages (e.g., Python, JavaScript, Ruby) for tool development and exploitation.
• Experience testing APIs (REST, SOAP) and cloud-native applications.
• Strong knowledge of secure SDLC principles and methodologies.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to articulate technical findings to diverse audiences.
• Relevant certifications such as OSCP, GPEN, GWAPT, CEH, CISSP are highly desirable.
• Ability to work independently and manage multiple testing engagements simultaneously.

Job Title: Software Quality Engineer

Job Description

As a Software Quality Engineer, you will lead Quality Engineering efforts for both software and hardware product development teams. You will be responsible for overseeing design control risk management and other quality engineering activities, ensuring the successful development and maintenance of new product development projects.

Responsibilities

• Provide Quality Engineering leadership for software and hardware product development teams.

• Lead design control risk management and other Quality Engineering activities for new product development projects.

• Establish and nurture strong relationships with cross-functional product development team members.

• Develop and maintain the Risk Management File, including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.

• Review and approve the Design History File and associated documentation.

• Oversee product development plans, design inputs and outputs, verification and validation, and review of test planning protocols and reports.

• Guide statistical methods and analyses for design verification and validation, including test method validation.

• Serve as the Subject Matter Expert for software quality and collaborate on code reviews and software security analysis.

• Lead implementation of best practices for software quality processes.

• Participate in design reviews to ensure effective development, transfer, and maintenance of product hardware and software.

• Support successful transfer and hyper-care phase of design and design modifications into production/field deployment.

• Provide Quality Engineering support for anomalies encountered in production and development projects.

• Lead changes to the Quality System based on new regulations and industry standards.

• Resolve and timely close CAPAs related to the design control process.

• Support released products interfacing with customer support representatives and account executives.

Essential Skills

• Experience with FDA CFR 820, IEC series, and IEC standards.

• Design development, verification, validation, and test activities for medical device hardware and software.

• Deployment of quality engineering tools for design and process improvement.

• Exceptional verbal and written communication skills.

• Proven ability to manage multiple projects and prioritize work independently.

• Advocate for quality and regulatory compliance.

• Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.

• 8 years of progressive Quality Engineering experience in the Medical Device industry.

Additional Skills & Qualifications

• Certified ASQ CQE and/or Six Sigma Black Belt/Green Belt preferred.

• Experience with artificial intelligence and working within an AAMI TIR45 framework.

• Experience supporting development of AI software algorithms and understanding of cloud infrastructure.

• B.S./M.S. in a relevant engineering field or equivalent scientific degree.

Work Environment

This role offers the possibility of temp to hire and operates on a hybrid schedule. The working hours are 8am-5pm Pacific Time. Local candidates are preferred, with a requirement to come to the office regularly, approximately 3 days per week, or as needed. Remote work is possible with some travel to the site.

We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:

· Medical, dental & vision

· 401(k)/Roth

· Insurance (Basic/Supplemental Life & AD&D)

· Short and long-term disability

· Health & Dependent Care Spending Accounts (HSA & DCFSA)

· Transportation benefits

· Employee Assistance Program

.Time Off/Leave (PTO, Vacation or Sick Leave)

Pay and Benefits

The pay range for this position is $90.00 - $105.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Bellevue,WA.

Application Deadline

This position is anticipated to close on Aug 26, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.

At Red Hat, we connect an innovative community of customers, partners, and contributors to deliver an open source stack of trusted, high-performing solutions. We offer cloud, Linux, middleware, virtualization, and AI technologies, together with award-winning global customer support, consulting, and implementation services. Red Hat is a rapidly-growing company supporting more than 90% of Fortune 500 companies.

About the Job

At Red Hat, our commitment to open source innovation extends beyond our products - it's embedded in how we work and grow. Red Hatters embrace change - especially in our fast-moving technological landscape - and have a strong growth mindset. That's why we encourage our teams to proactively, thoughtfully, and ethically use AI to simplify their workflows, cut complexity, and boost efficiency. This empowers our associates to focus on higher-impact work, creating smart, more innovative solutions that solve our customers' most pressing challenges.

Red Hat's Global Engineering team is looking for an experienced Software Quality Engineer to join the Agentic and AI Engineering Tools team. In this role, you'll contribute directly to Red Hat's rapidly growing AI/ML family of products and will be responsible for developing and maintaining test strategies and frameworks, designing and implementing automated tests, and creating and carrying out test plans. Quality engineers in this role will participate in standard quality practices, design reviews, automated testing, and productization for major product features and bug fixes. In addition, you may have to consider novel ways for testing non-deterministic systems and code, as well as pay close attention to potential sources of bias that may be introduced during model build and training.

What you will do

• Collaboratively design and develop automation test plans and scripts.

• Partner with Product Management, User Experience, and Development to identify and incorporate customer needs and use cases into testing strategies and feature designs.

• Execute manual and automated tests and deliver clear status updates in a timely manner.

• Advocate for the resolution of critical issues and communicate the impact on customers to the development team(s).

• Monitor and participate in upstream AI/ML communities, evaluating new AI/ML-related technologies in the space and considering potential integrations and collaborations upstream.

• Run technical initiatives that grow, improve, and scale our existing processes.

• Regularly communicate with project stakeholders including other teams of Red Hat engineers, product managers, consultants, management, and senior leadership.

• Explore and experiment with emerging AI technologies relevant to software development, proactively identifying opportunities to incorporate new AI capabilities into existing workflows and tooling.

• Leverage AI-driven testing frameworks to automate test case generation, optimize test execution, identify potential edge cases, and enhance overall test coverage and reliability.

What you will bring

• 3+ years of experience as a Software Quality Engineer, Software Development Engineer in Test, or similar role.

• Experience with scripting and creating automation in Python and Bash.

• Experience creating automation for GitHub, using GitHub Actions or related continuous integration tools.

• Experience developing unit, functional, and end-to-end (E2E) test cases and automation.

• Familiarity with AI and Machine Learning platforms, tools, and frameworks, such as PyTorch, LLaMA.cpp, vLLM, Kubeflow, and Docling.

• Ability to quickly learn and use new tools and technologies .

Following is considered a plus

• Experience working with Kubernetes/OpenShift and containers.

• Understanding of DevOps methodology, scrum, and/orJira.

• Experience with hardware accelerators such as CUDA and ROCm.

• Bachelor's degree in computer science or related discipline.

#LI-MD1

#AI-HIRING

The salary range for this position is $80,770.00 - $129,160.00. Actual offer will be based on your qualifications.

Pay Transparency

Red Hat determines compensation based on several factors including but not limited to job location, experience, applicable skills and training, external market value, and internal pay equity. Annual salary is one component of Red Hat's compensation package. This position may also be eligible for bonus, commission, and/or equity. For positions with Remote-US locations, the actual salary range for the position may differ based on location but will be commensurate with job duties and relevant work experience.

About Red Hat

Red Hat ( is the world's leading provider of enterprise open source ( software solutions, using a community-powered approach to deliver high-performing Linux, cloud, container, and Kubernetes technologies. Spread across 40+ countries, our associates work flexibly across work environments, from in-office, to office-flex, to fully remote, depending on the requirements of their role. Red Hatters are encouraged to bring their best ideas, no matter their title or tenure. We're a leader in open source because of our open and inclusive environment. We hire creative, passionate people ready to contribute their ideas, help solve complex problems, and make an impact.

Benefits

? Comprehensive medical, dental, and vision coverage

? Flexible Spending Account - healthcare and dependent care

? Health Savings Account - high deductible medical plan

? Retirement 401(k) with employer match

? Paid time off and holidays

? Paid parental leave plans for all new parents

? Leave benefits including disability, paid family medical leave, and paid military leave

? Additional benefits including employee stock purchase plan, family planning reimbursement, tuition reimbursement, transportation expense account, employee assistance program, and more!

Note: These benefits are only applicable to full time, permanent associates at Red Hat located in the United States.

Inclusion at Red Hat

Red Hat's culture is built on the open source principles of transparency, collaboration, and inclusion, where the best ideas can come from anywhere and anyone. When this is realized, it empowers people from different backgrounds, perspectives, and experiences to come together to share ideas, challenge the status quo, and drive innovation. Our aspiration is that everyone experiences this culture with equal opportunity and access, and that all voices are not only heard but also celebrated. We hope you will join our celebration, and we welcome and encourage applicants from all the beautiful dimensions that compose our global village.

Equal Opportunity Policy (EEO)

Red Hat is proud to be an equal opportunity workplace and an affirmative action employer. We review applications for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, ancestry, citizenship, age, veteran status, genetic information, physical or mental disability, medical condition, marital status, or any other basis prohibited by law.

Red Hat does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for, and will not pay, any fees, commissions, or any other payment related to unsolicited resumes or CVs except as required in a written contract between Red Hat and the recruitment agency or party requesting payment of a fee.

Red Hat supports individuals with disabilities and provides reasonable accommodations to job applicants. If you need assistance completing our online job application, email . General inquiries, such as those regarding the status of a job application, will not receive a reply.

Description:

You will be the Software Quality Engineer for the Lockheed Martin team. Our team is responsible for developing and maintaining high-quality software systems.

What You Will Be Doing

As the Software Quality Engineer, you will be responsible for ensuring the quality of software systems and processes. You will develop and maintain Systems and Software Quality Engineering common processes that are aligned with AS9100 Quality Management System, Program, and Customer requirements.

Your responsibilities will include:

• Developing, modifying, and applying quality principles to the development and use of software and software-based systems
• Designing and implementing software development and maintenance processes
• Defining audit strategy to ensure compliance to systems/software processes
• Evaluating and analyzing software quality systems for deficiency identification and correction
• Performing software product reviews against contractual, technical, and/or process requirements

Why Join Us

We are looking for a collaborative and detail-oriented individual who is passionate about software quality engineering. As a Software Quality Engineer at Lockheed Martin, you will have the opportunity to work on challenging projects, collaborate with a talented team, and contribute to the development of high-quality software systems. You will be part of a company culture that encourages employees to build their careers, leverage their knowledge, and achieve challenging goals.

We are committed to supporting your work-life balance and overall well-being, offering flexible scheduling options. Learn more about Lockheed Martin's comprehensive benefits package here ( .

Further Information About This Opportunity

This position is located in Orlando, FL. Discover more about our Orlando, Florida location. (

MUST BE A U.S. CITIZEN - This position is located at a facility that requires special access. The selected candidate must be able to obtain a secret clearance.

Basic Qualifications:

-Bachelors degree or higher in STEM

-Must be able to obtain a Secret clearance

-Travel may be required to support program activities

-Software Quality, Software Engineering, or Systems Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test

-Ability to interpret software design and code to verify implementation of requirements

-Experience with product development phases

-Effective Communication Skills: Written, Oral, Listening, Presentation, Technical Writing

-Demonstrated basic understanding of audit techniques

Desired Skills:

-Proficient skill level with Microsoft Office applications: Word, Excel, PowerPoint, etc.

-Demonstrated ability to use causal analysis tools to analyze and resolve technical/process issues varying from basic to very complex

-Lean Six Sigma (Green Belt)

-Effective interpersonal skills, including Team building and Collaboration

-Experience with presentation & problem solving skills

-Experience with Government customers

-Strong knowledge of Industry recognized Quality Systems/Models such as Capability Maturity Model Integration (CMMI), QMS System Audit (AS9100, ISO9001)

-Experience with verification and validation processes

-Different program phase experience (development, production, sustainment)

-Handling and Dispositioning Nonconformances

Security Clearance Statement: This position requires a government security clearance, you must be a US Citizen for consideration.

Clearance Level: Secret

Other Important Information You Should Know

Expression of Interest: By applying to this job, you are expressing interest in this position and could be considered for other career opportunities where similar skills and requirements have been identified as a match. Should this match be identified you may be contacted for this and future openings.

Ability to Work Remotely: Onsite Full-time: The work associated with this position will be performed onsite at a designated Lockheed Martin facility.

Work Schedules: Lockheed Martin supports a variety of alternate work schedules that provide additional flexibility to our employees. Schedules range from standard 40 hours over a five day work week while others may be condensed. These condensed schedules provide employees with additional time away from the office and are in addition to our Paid Time off benefits.

Schedule for this Position: 4x10 hour day, 3 days off per week

Lockheed Martin is an equal opportunity employer. Qualified candidates will be considered without regard to legally protected characteristics.

The application window will close in 90 days; applicants are encouraged to apply within 5 - 30 days of the requisition posting date in order to receive optimal consideration.

At Lockheed Martin, we use our passion for purposeful innovation to help keep people safe and solve the world's most complex challenges. Our people are some of the greatest minds in the industry and truly make Lockheed Martin a great place to work.

With our employees as our priority, we provide diverse career opportunities designed to propel, develop, and boost agility. Our flexible schedules, competitive pay, and comprehensive benefits enable our employees to live a healthy, fulfilling life at and outside of work. We place an emphasis on empowering our employees by fostering an inclusive environment built upon integrity and corporate responsibility.

If this sounds like a culture you connect with, you're invited to apply for this role. Or, if you are unsure whether your experience aligns with the requirements of this position, we encourage you to search on Lockheed Martin Jobs , and apply for roles that align with your qualifications.

Experience Level: Experienced Professional

Business Unit: MISSILES AND FIRE CONTROL

Relocation Available: Possible

Career Area: QA/Test and Inspection

Type: Full-Time

Shift: First

The Software Quality Engineer (SQE) within Quality and Regulatory organization plays a critical role in ensuring that software whether embedded in products, supporting clinical workflows, or used in enterprise quality systems meets rigorous internal quality standards and global regulatory requirements.

The SQE is responsible for driving and executing software validation activities across the development lifecycle, contributing to design control, risk management, and audit readiness initiatives to maintain the integrity, reliability, and compliance of all GxP-relevant software systems.

While this is a largely remote role, the ideal candidate will be within range of a major Quest site. Sites include Secaucus, NJ, Clifton, NJ, Marlborough, MA, Wood Dale, IL, Lenexa, KS, Dallas, TX, Pittsburgh, PA, and Houston, TX.

Design Control & Risk Management

• Ensure all software development activities comply with FDA 21 CFR Part 820 and ISO 13485
• Participate and contribute to Design inputs/outputs reviews, verification and validation planning, Design transfer, and Design history file compilation.
• Lead or contribute to hazard analysis and risk assessment using ISO 14971

Validation Testing and Documentation

• Ensure documentation is complete, reviewable, and audit ready.
• Collaborate with Document Control to ensure controlled documents (SOPs, test records, validation packages) are managed appropriately.
• Ensure all documents are compliant with company policy, regulation requirements, and standards.
• Maintain hard copy records in accordance with Quest's retention policy.
• Create standard templates for validation and testing deliverables.
• Author and revise procedures and work instructions related to SDLC, validation lifecycle, change control, and risk management.

Software Validation (CSV/SDLC)

• Develop validation plans for LIMs, QMS software, and other GxP Systems
• Define and execute User Requirements Specifications (URS), Functional and configuration specifications, IQOQPQ protocols, and test scripts (Manual and automated)
• Oversee software risk classification and mitigation plans.
• Drive generation and preparation of documentation, records, and other artifacts in support of regulatory submissions.
• Perform process audits and implement improvements to reduce cycle times and increase validation efficiency.
• Lead root cause analysis for software nonconformances, validation failures, defect leakage to production.
• Participate in audits

Required WorkExperience:

• 5+ years of experience in Software Development and Validations in medical device and/or IVD industry.
• Hands-on experience with software validation (CSV) including authoring, review, and root-cause analysis of validation deliverables.
• Lead experience on validation projects and ownership of full software validation lifecycle.
• Demonstrated Experience applying Medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 15189, IVDR, CAP, and CLIA).

Preferred Work Experience:

• Experience with IEC 62304- Software Lifecycle for Medical Devices
• Experience validation cloud-bases systems (e.g. SaaS Platforms, AWS)
• Experience with Cybersecurity validation, secure SDLC, or Software as a medical device (SaMD)
• Experience with EU MDR/IVDR and international regulatory submissions
• Experience with eQMS systems such as MasterControl, Trackwise, or Veeva
• ASQ CSQE (Certified Software Quality Engineer) or medical device related certification, or CSV/GAMP 5 training

Physical and Mental Requirements:

• Strong attention to detail for thorough documentation to ensure consistency in documentation.
• Excellent problem-solving skills to identify and address quality issues effectively.
• Ability to manage multiple work projects to meet deadlines while maintaining accuracy.
• Must be able to occasionally move and lift objects of up to 25 pounds.

Knowledge:

• Broad-based technical knowledge and skills of software validation principles in regulated environment, design controls, risk management (ISO 14071).
• Demonstrated knowledge for software development lifecycle models (waterfall, Agile, V-model)
• Strong working knowledge of applicable regulations, such as but not limited to, the medical device regulations: FDA 21 CFR Part 820 Quality Systems Regulations/new Quality Management System Regulation and ISO 13485 standards. Preferred: ISO 14971, ISO 15189, IVDR, CAP, CLIA, and NYSDOH requirements.

Skills:

• Computer System Validation of software used in regulated environments following GAMP 5 and FDA 21 CFR Part 11
• Test planning and Execution including writing test protocols and executing manual or automated testing.
• Building requirements traceability matrices
• Applying risk-based validation based on ISO 14071 and GAMP principles to prioritize validation efforts.
• Ability to work independently and collaboratively with cross-functional departments in a fast-paced environment with minimal supervision.
• Proficient in document management systems.