Lead, Quality Assurance

92409 San Bernardino, California FedEx

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Lead - Quality Assurance

Pay: $22.00/hour

Shift: 1st Shift Monday-Friday, 5:00am-1:30pm

Location: 1295 E Central Ave, San Bernardino, CA 92408

About FedEx Supply Chain

FedEx Supply Chain, a subsidiary of FedEx Corp. (NYSE: FDX), is a leader in the third-party logistics industry offering a diverse service portfolio that enables commerce for businesses. With a proven track record of innovation and operational excellence, FedEx Supply Chain takes a consultative approach to optimize logistics processes, implement innovative technology and drive continuous improvement. By leveraging best practices and the world-renowned FedEx network, FedEx Supply Chain delivers leading solutions that provide flexibility, enable scalability and improve cost-effectiveness for customers. Through more than 11,000 employees, 130 operations and 35 million square feet of warehouse space, FedEx Supply Chain manages nearly 150 million packages and processes 358 million returns each year. For more information, go to supplychain.fedex.com.

We Have
  • A strong FedEx brand consistently ranked among the worlds most admired and trusted employers.
  • A top notch leadership team with the experience needed to grow and develop your career.
  • An open mind for new ideas and creative methods.
  • A strong compensation and benefits package, including health, vision, dental, 401k with a strong match and much more!
General Summary

The Quality Assurance Lead is responsible for ensuring quality functions in all daily operations. They will perform collection data, reporting, monitoring, and auditing to ensure compliance and drive other quality related metrics.

This position will be responsible for.
  • Support the collection of data and analyze for regulatory reporting, coordinate and develop reports, and assessment tools to verify compliance.
  • Ensure quality metrics are adequately captured, analyzed and communicated to management for improvement activities.
  • Lead in investigation and resolve product specification related problems.
  • Participate in internal audits.
  • Monitor the internal audit process to ensure compliance with the schedule, including verification of any follow-up audits, commitments, or corrective actions.
  • Supports QA Department daily activities.
  • Support in the preparation of and during audits, including gathering documents and quality records.
  • Ensure quality records are filed and archived.
  • Ensure adequate controls are maintained regarding damage and safe transport of product within warehouse.
  • Assist the Quality Assurance Supervisor with tracking and trending KPIs, quality metrics, etc. to determine if corrective actions need implemented.
  • Ensures a high standard of performance and conformance to Quality Management Systems.
  • Lead in maintaining processes that support the QA function for consistency.
  • Perform inventory research activities within the WMS (Warehouse Management System).
  • Lead and drive continual improvement utilizing established quality process.
  • Represent Quality Assurance when supporting other quality and compliance related activities as needed.
  • Communicate with customers regarding timing of completed quality activities.
  • Work with other departmental Leads, Supervisors, Managers, and Senior Management to achieve a timely cohesive decision-making process.
  • Performs additional tasks as assigned with minimal supervision.
You might be a great fit if. Education/Experience

High school diploma or GED and 3-5 years of Quality Assurance experience in GMP or similarly regulated facility. Proficient computer skills with MS Word, Excel, and PowerPoint. Strong written and verbal communications skills. Customer service driven. Strong team player.

Physical/Cognitive Requirements

With or without accommodation: Ability to follow policies and procedures. Ability to read, write and interpret information. Ability to add, subtract, multiply and divide. Ability to use hands to finger, handle, or feel. Ability to sit/walk/stand for up to 10 hours per day. Ability to intermittently crawl, squat, climb, twist, bend, stoop, push or pull. Must possess visual acuity, i.e., close, distance, and color vision, depth perception and the ability to adjust focus. Ability to lift/carry items less than 40 pounds.

ADA FedEx Supply Chain will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. Reasonable accommodations are available for qualified individuals with disabilities throughout the subsequent application process. FedEx Supply Chain is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Job ID: 48785

Schedule: Full-time

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Quality Assurance Supervisor

92725 Santa Ana, California gpac

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Job Description

Los Angeles, California (on-site)

We are searching for a Quality Assurance Supervisor to their team. This company has been in business since 2002, and they have been growing ever since. They have become well recognized & respected in the industry for providing quality, service, and competitively priced products. They make a variety of different soup bases & seasonings, and recently opened a division.

The ideal candidate will have:
  • 5+ years of Quality Assurance experience in the food industry,
  • Experience with SQF,
  • USDA & FDA regulations,
  • Food science, biology, chemistry, or a degree in a related field.

They're offering a competitive salary, plus bonus, full benefits, and 401k match. If you're interested, please apply or email your resume to

keywords: food manufacturing, quality assurance, soup, coffee, tea, seasonings, QA, quality assurance, food, beverage

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations. GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
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Quality Assurance Manager

92713 Irvine, California VALID8 Financial

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Job Description

We are seeking a Quality Assurance Manager to join our team. The position will partner with Good Cultures Quality Leadership and Supply Chain Team to ensure product excellence, regulatory compliance, and continuous improvement in quality, process, and systems. The positions main responsibility will be to work collaboratively with our co-packing partners to ensure that all of Good Cultures quality standards, process standards, SOPs, sampling and testing requirements related to our product are meeting the agreed upon operating standards and procedures necessary to deliver gold standard product every day at all co-man locations.

ESSENTIAL JOB RESPONSIBILITIES :

  • Work with the co-man quality, sanitation and production teams to correct or improve the quality of our Good Culture products. Includes onsite Gold Standard recalibration training with each co-man a minimum of annually
  • Assist In developing food safety and quality programs and SOPs, and ensure documents are properly controlled. Perform training on these SOPs Internally and/or externally with co-mans where applicable
  • Create a best-In-class sensory program to define and deliver Gold Standard Product and execute plan to reduce variability in network
  • Investigate quality-related customer complaints and non-conformance issues. Management of non-conformances through a root cause/CAPA process
  • Direct involvement and auditing of the sample retain program. Ensure that all co-mans are adhering to the sampling requirements (amount and type) each week and assist Sr. FSQA Specialist with the management and monitoring of this program
  • Review compiled sensory, microbial and product specification statistical quality data to ensure compliance or identify any non-conformance trends
  • Support the commissioning & onboarding of new co-man facilities through onsite visits and participation in any trial runs occurring at each facility
  • Audit 3PLs with the Logistics Manager to ensure quality guidelines are being met. Non-conformance observations resolved through a root cause/CAPA process
  • Provide support in case of need to the Sr. FSQR Specialist with customer database and portal management and maintenance
  • Maintain all regulatory certifications including Organic, Kosher, and GFCO and lead necessary inspections to uphold certification
  • Help to implement our mission and ensure your work has a positive impact on our environmental and social responsibilities
  • Leverage opportunities to highlight Good Cultures mission and impact to inspire others to join us in doing good
  • Have fun and make a difference
  • 50% travel is required, which ebbs & flows based on business needs

JOB QUALIFICATIONS/REQUIREMENTS:

  • Bachelor of Science Degree in Food Science, Microbiology or closely related field preferred
  • 5 to 7 years of Quality experience in a food plant (preferably dairy). Cross functional experience Including time in R&D or Operations a plus
  • Certifications: SQF, PCQI, Quality Auditor, Quality Engineer, Continuous Improvement, GMPs, HACCP, SQF
  • Experience with implementation of corrective action programs
  • Sanitation/CIP knowledge and experience strongly preferred
  • Sensory Program Experience
  • Ability to interact effectively with third party and internal auditors
  • Ability to influence management & enable the activities of employee teams
  • Excellent oral and written communication skills
  • Strong computer and document management skills

About Good Culture:

We believe that if you eat good things, and surround yourself with good, youll feel good. Simple as that. Thats why we decided to create a food company that offers real organic ingredients from trusted sources, promotes good health and tastes great. Our mission is to reinvent the food system, from the (actual) ground up. We are a cultured dairy company that currently makes pasture-raised cottage cheese, probiotic rich sour cream, cream cheese and probiotic milk. Were on the look for some cultured healers!

Good Culture is an equal opportunity employer. At Good Culture we also believe a great culture fosters and values a diverse, equitable, and inclusive workforce. We seek individuals of all backgrounds and experiences to apply for this position. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Good Culture is committed to creating an inclusive environment for all employees.

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Quality Assurance Supervisor

92504 Riverside, California BlueTriton

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Primo Brands is a leading branded beverage company in North America with a focus on healthy hydration. We are proud to offer an extensive and iconic portfolio of highly recognizable, sustainably sourced, and conveniently packaged branded beverages distributed across more than 150,000 retail outlets. Job Description We are currently seeking a Quality Assurance Supervisor (Resource) to be based in Cabazon, CA, reporting to the Quality Assurance Manager. Pay Range: $93,351 - $104,438. This role is eligible for an annual bonus. Key Responsibilities: Lead a team of 4 QA Techs to achieve quality metrics in line with our culture and values. Partner cross-functionally with Planning, Production, and Warehouse teams to maximize results. Support BlueTriton Brands' Continuous Excellence (BCE) and TPM initiatives. Coach, mentor, and develop team members to meet current and future business needs. Assist in leading quality initiatives and audits locally. Track, analyze, and lead initiatives for quality and customer complaint issues. Ensure compliance and proper record-keeping for quality checks, testing, sampling, and sanitation activities. Manage budgeting, purchasing, and inventory of plant supplies. Implement continuous improvement methodologies to enhance quality processes. Ensure compliance with good hygiene practices, GMPs, and HACCP. Communicate new quality programs and facilitate training for plant personnel. Manage plant water sources and oversee water usage reporting. Maintain records within the laboratory. Qualifications: Bachelor's Degree in Chemistry, Biology, or related field, or equivalent experience. At least 5 years of quality assurance experience in food, beverage, or pharma manufacturing, with 2+ years in a supervisory role. Experience with quality and hygiene regulations, including FDA requirements. Knowledge of analytical, microbiological, and sensory testing. Understanding of GLP, GMP, HACCP, and sanitation standards. Familiarity with Six Sigma, TPM, and problem-solving methodologies. Strong computer skills, including Word, Excel, PowerPoint, and SAP. Excellent communication, leadership, and project management skills. Willingness to respond to after-hours calls and provide occasional weekend coverage. Note: The salary range is an estimate based on market data and may vary depending on qualifications and location. We are committed to fair compensation and encourage open discussions during interviews. Additional Information Primo Brands' portfolio includes major brands like Poland Spring, Arrowhead, Deer Park, and others. We are dedicated to providing healthy hydration and fostering a diverse, inclusive workplace. We consider qualified applicants with criminal histories in accordance with applicable laws. Create a job alert for this search Quality Assurance Supervisor • Riverside, CA, United States #J-18808-Ljbffr

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Supervisor, Quality Assurance

91768 Pomona, California Abbott

Posted 2 days ago

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Job Title: Supervisor, Quality Assurance

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • An excellent retirement savings plan with a high employer contribution
  • Tuition reimbursement, the student debt program, and education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The position of Supervisor, Quality Assurance is within our Toxicology Business Unit located in Pomona, CA. This role is responsible for supervising specific quality systems.

What you'll do:

  • Supervise and oversee specific areas of Quality Assurance or Quality Control.
  • Supervise the activities, manpower, and resources within the area to ensure support is provided to meet the department and company goals.
  • Respond to complaints on parts and work orders, plan and implement projects and procure needed equipment, supplies, and spare parts.
  • May implement policies and procedures to maintain production compliance.
  • Monitor daily work operations and provide direction to predominantly nonexempt and entry level staff to achieve unit or departmental goals.
  • Review and approve change orders.
  • Develop and report batch record review performance indicator metrics to management team.
  • Monitor compliance with company policies and procedures.
  • Provide secondary support for other quality subsystems.
  • Develop work schedules for department by assessing priorities, workload, and available resources.
  • Lead the activities of assigned staff by communicating and providing guidance towards achieving department objectives.
  • Schedule human and material resources within a department or section in conjunction with near-term plans to ensure their availability; carry out operations within an established budget.
  • Promote department goals by selecting, motivating, and training capable staff.
  • Maintain personnel records (e.g., work schedules, vacation schedules, leaves) and make or direct modifications in the database to reflect actual changes.
  • Maintain quality system records through the establishment of a centralized documentation archiving system.
  • Manage physical quality system records for cataloging, archival, retrieval, and scheduled destruction of records in accordance with established procedures.

Assignments are expressed in the form of tasks; generally, makes day-to-day decisions within established policies, procedures, and guidelines in order to carry out the operations and processes selected at higher levels; consequences of erroneous decisions or recommendations might include delays in program schedules and result in the allocation of more resources.

Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.

Carries out duties in compliance with established business policies.

Demonstrates commitment to the development, implementation, and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.

Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities.

Perform other duties and projects as assigned.

Required qualifications:

  • Bachelor's degree in related discipline or equivalent experience.
  • A minimum of three to five years of experience with one to three years of progressively responsible positions in Quality Assurance.
  • Minimum 4 years' experience in a lead or supervisory position.
  • Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostics.
  • Excellent written and verbal communication skills.

Preferred:

  • Expert in using computers, specifically MS Office (MS Word/Excel).
  • Able to understand and adhere to quality documentation.
  • Position requires ability to jointly develop, implement, evaluate, and/or modify ongoing best practices to assure overall operational effectiveness.
  • Knowledge of the QSR or ISO 13485 is a plus.
  • Excellent organization skills must be able to manage many simultaneous projects.

The base pay for this position is $79,500.00 $138,700.00. In specific locations, the pay range may vary from the range posted.

Job Family: Operations Quality Division: CMI ARDx Cardiometabolic and Informatics Location: United States > Pomona : 829 Towne Center Drive Additional Locations: Work Shift: Standard Travel: Not specified Medical Surveillance: Not Applicable Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment, Work in noisy environment

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

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Quality Assurance Supervisor

92641 Garden Grove, California gpac

Posted 2 days ago

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Job Description

We are seeking a detail-oriented and proactive Quality Assurance Supervisor to oversee day-to-day quality assurance operations and ensure that products meet company and regulatory standards. The QA Supervisor will lead a team of QA technicians/inspectors, implement quality control systems, and work closely with production, engineering, and compliance teams to maintain consistent product quality.

Key Responsibilities:

  • Supervise and mentor QA staff across shifts, ensuring compliance with company policies and procedures.
  • Monitor and enforce GMP (Good Manufacturing Practices), HACCP, ISO, or other relevant standards depending on the industry.
  • Investigate product quality issues and work with cross-functional teams to implement corrective and preventive actions (CAPAs).
  • Conduct audits (internal, supplier, regulatory) and prepare required documentation and reports.
  • Maintain QA documentation, including batch records, inspection reports, and deviation logs.
  • Develop and implement quality inspection protocols and ensure proper training of team members.
  • Participate in continuous improvement initiatives and root cause analysis.
  • Support regulatory compliance by staying current on relevant industry standards and regulations.
Qualifications:
  • Bachelor's degree in Quality, Engineering, Food Science, Life Sciences, or a related field (or equivalent experience).
  • 3+ years of quality assurance experience in food production
  • 1+ year of supervisory or team lead experience preferred.
  • Strong knowledge of quality systems (ISO 9001, HACCP, GMP, etc.).
  • Excellent communication, leadership, and problem-solving skills.
  • Proficient in Microsoft Office and quality management software (QMS) systems.
Preferred Qualifications:
  • Experience with Lean, Six Sigma, or continuous improvement methodologies.
  • Bilingual (Spanish/English) a plus.
Why Join Us:
  • Competitive salary and benefits
  • Growth and development opportunities
  • Collaborative and safety-first work environment

If you're interested and serious, please send your confidential resume to Brittany at for immediate consideration!

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations. GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
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Quality Assurance Manager

91760 Norco, California LHH

Posted 6 days ago

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Creating a Beautiful Working World by Empowering Engineering and Supply Chain Excellence at LHH Recruitment Solutions

The Quality Manager is responsible for leading all quality-related functions and personnel within the organizations production operations. This role ensures the effective implementation and continuous improvement of the quality management system in accordance with industry standards and internal procedures.

Responsibilities include:

  • Managing the quality management system to ensure compliance with applicable standards and internal protocols.
  • Leading internal and external audits, including those related to industry certifications and customer requirements.
  • Acting as the primary point of contact for all quality-related customer communications.
  • Supervising and supporting:
  • Quality Engineering: Driving continuous improvement initiatives, managing customer quality interactions, and overseeing corrective actions.
  • Quality Assurance: Conducting First Article Inspections (FAI) and managing supplier quality representation activities.
  • Inspection Team: Ensuring all products meet defined inspection and quality standards.

Qualifications:

  • Bachelors degree or equivalent professional experience.
  • At least 5 years of relevant experience in a regulated manufacturing environment, preferably in aerospace or a similarly complex industry.
  • Proficiency in English (reading, writing, and speaking).
  • Strong organizational and leadership skills.
  • Working knowledge of AS9100 standards and experience maintaining compliance with them.
Seniority level
  • Seniority level Mid-Senior level
Employment type
  • Employment type Full-time
Job function
  • Job function Quality Assurance
  • Industries Aviation and Aerospace Component Manufacturing and Manufacturing

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About the latest Quality assurance Jobs in Eastvale !

Quality Assurance Director

92504 Riverside, California Electronic Careers

Posted 6 days ago

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Director of Quality, North America – connectors & cable – San Diego The Director of Quality is responsible for establishing and maintaining high-quality standards throughout the product and customer life cycle, ensuring compliance with regulations and customer needs, and driving continuous improvement initiatives. Responsibilities • Leadership & Quality Culture: Leads the Quality team towards excellence in product quality and operational success, fostering a culture that prioritizes quality and puts customers first. Champions continuous improvement and quality excellence, embedding quality in every aspect of operations. • Strategic Partnership: Collaborates cross-functionally with colleagues in Supply Chain, Sales, Customer Service, Engineering, and Applications Center to drive the Quality strategy for North America. Shares best practices with Global Quality functions to create alignment and collaboration. • Quality Management: Oversees the development and maintenance of Quality programs, systems, processes, and procedures that ensure compliance with policies and standards. This includes customer, supplier, and product quality processes. Provides expertise in interpreting policies and regulations to ensure compliance. • Solution Leadership: Leads team to investigate quality issues, identify root causes, and develop corrective actions to prevent recurrence. • Audit Management: Leads and directs audit preparation, resolving findings. • Continuous Improvement: Cultivates a culture of continuous learning across all areas of responsibility, identifies the root causes of quality issues, and institutionalizes organizational learning. Stays abreast of regulatory requirements and industry standards. • Compliance Focus: Ensures compliance with all Quality system procedures to meet current regulatory and customer requirements (. ISO9001, AS9100, IATF 16949). • • Requirements • Bachelor’s degree in engineering, quality management, or related field • Certifications in Lean Six Sigma, CQE, CMQ/OE, or other Quality certifications are a plus • 10 or more years of experience in Quality Assurance / Quality Control; 5 or more years of experience leading a team as a Quality Manager or Director • Experience in military, medical, automotive, or aerospace manufacturing • In-depth knowledge of quality management principles, industry standards, and manufacturing processes • Familiarity with 8D or Fishbone methodologies is a plus. • Experience working with ERP/MRP systems (SAP highly preferred); • • Resume to: #J-18808-Ljbffr

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Quality Assurance Manager

92725 Santa Ana, California Brandywine Communications

Posted 12 days ago

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Position : Quality Assurance Manager

Department : Quality

Location : Santa Ana, CA

FLSA Status : Exempt, Full-Time

Job Summary:

Brandywine Communications is seeking a Quality Assurance (QA) Manager to lead our Quality department. The QA Manager is responsible for developing, implementing, and maintaining quality systems that ensure products consistently meet internal standards, industry regulations, and customer expectations. This position requires strong leadership, technical expertise, and cross-functional collaboration to support the companys manufacturing operations.

Key Responsibilities:
  1. Develop and maintain quality assurance policies and procedures in accordance with applicable industry standards and company objectives.
  2. Plan and conduct regular internal and external audits to ensure compliance with quality standards and drive continuous improvement.
  3. Monitor quality performance metrics, identify trends, and recommend corrective and preventive actions.
  4. Collaborate with cross-functional teams to ensure quality standards are met throughout all phases of production.
  5. Oversee and improve processes for inspecting, testing, and evaluating materials, in-process products, and final assemblies.
  6. Supervise and train quality inspectors and production staff in quality practices, documentation, and inspection criteria.
  7. Track products through the manufacturing process to ensure compliance with specifications at every stage.
  8. Conduct detailed inspections of finished goods to verify conformance to internal and external standards.
  9. Identify and investigate non-conforming materials or products; implement corrective actions and root cause analysis processes.
  10. Stay current with industry regulations, certifications, and best practices in quality assurance and continuous improvement.
Qualifications:
  1. 5-8 years of progressively responsible experience in quality assurance within a manufacturing environment.
  2. Strong knowledge of quality assurance methodologies and tools.
  3. Strong knowledge of AS9100, IPC J-Standards and general quality system requirements.
  4. Experience with the manufacture and inspection of printed circuit boards.
  5. Ability to manage multiple projects and priorities in a fast-paced environment.
  6. Experience supervising quality teams and working with cross-functional departments.
Physical Requirements:
  1. Ability to stand for long periods and occasionally lift up to 10 lbs.
  2. Manual dexterity and visual acuity to inspect small components and operate test and inspection equipment.
Additional Information:

The Key Responsibilities are an outline of the general nature and level of work performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and qualifications. The company may amend or modify duties based on business needs in accordance with applicable California labor laws. Reasonable accommodations may be made for qualified individuals with disabilities.

Equal Opportunity Employer Statement:

Brandywine Communications is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local laws.

We strive to create a workplace that is inclusive, respectful, and reflective of the diverse communities we serve. If you require accommodation during any part of the application or hiring process, please contact Human Resources at .

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Sr. Quality Assurance Engineer

92713 Irvine, California Prismatik

Posted 1 day ago

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Description Position at Prismatik Essential Functions:Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices.Responsible for the administration of the QMS software.Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements.Integrates ISO 14971, ISO 13485, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes.Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework.Provides CAPA, complaints, audit and overall QMS support in regards to software.Performs other related duties and projects as business needs require at direction of management.Minimum Qualifications:Bachelor's degree in Engineering, Biomedical, or related technical field or equivalent practical experience.Minimum of eight (8) years of related experience in the FDA QSR/ISO 13485 medical device industry.Advance knowledge with development and test requirements with recognized standards (ISO 13485).Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the Prismatik practices and the QMS.Pay range: $85,554.38 - $130,000/yr.Exact compensation may vary based on skills and experience.Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at (email protected). Please indicate the specifics of the assistance needed. Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.

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