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Flexible Quality Engineer Fda Jobs (NOW HIRING)

Innovative Health LLC

Quality Engineer

Scottsdale, AZ · On-site

$70K - $90K/yr

The Quality Engineer will ensure compliance to required standards including FDA and ISO during process development and the manufacturing of medical device components. In addition, this person will ...

Intellectt INC

Senior Quality Engineer

North Haven, CT · On-site

$88K - $119K/yr

Ensure compliance with FDA, ISO 13485, and quality management system requirements. Required Qualifications * Bachelor's degree in Engineering or related technical field. * 4+ years of Quality ...

Intellectt INC

Supplier Quality Engineer

San Diego, CA · On-site

FDA & ISO 13485 Compliance * Supplier Quality Issue Resolution * Risk Assessment & Continuous Improvement * Cross-functional Collaboration with Engineering, Manufacturing & Purchasing Requirements:

Exalta Group

Quality Engineer

Bonita Springs, FL · On-site

$67K - $87K/yr

Experience with FDA 21 CFR Part 820/QMSR and ISO 13485. * Strong knowledge of CAPA, root cause ... ASQ Certified Quality Engineer (CQE) * Six Sigma Green Belt or Black Belt Key Competencies

Actalent

Quality Engineer

Irvine, CA · On-site

$57 - $63/hr

Quality Engineer We are seeking a Quality Engineer to join a growing medical device contract ... Maintain and improve Quality Management System (QMS) processes in accordance with FDA QMSR, ISO ...

Actalent

Quality Engineer

Miami, FL

$68K - $88K/yr

Quality Engineer (Sterilization) The Quality Engineer plays a key role in ensuring that innovative ... Working knowledge of US FDA and international regulatory requirements for medical devices.

Intellectt INC

Sr. Quality Engineer

North Haven, CT · On-site

$88K - $119K/yr

... FDA and ISO requirements. Key Responsibilities: · Support manufacturing quality and product ... Required Qualifications · Bachelor's degree in Engineering or related technical field. · 4+ years ...

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH · On-site

$56K - $73K/yr

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...

MPE-Inc

Quality Engineer

Milwaukee, WI · On-site

$74K - $95K/yr

Ensure assigned quality engineering activities comply with ISO 13485, applicable FDA/QMS requirements, customer requirements, and MPE quality system procedures. * Review drawings, specifications ...

Convergent Dental, Inc.

Quality Engineer

Waltham, MA · On-site

$90K - $135K/yr

Ensure compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part ... Flexible work from home options available. Compensation: $90,000.00 - $135,000.00 per year We are ...

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH · On-site

$56K - $73K/yr

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...

Germfree Laboratories Inc

Quality Engineer

Ormond Beach, FL · On-site

$63K - $81K/yr

Quality Engineer · Department: Quality Engineering · Location: Ormond Beach, FL (USA) · ... Its products are engineered to support a range of customer and industry standards (cGMP / FDA 21 ...

Intellectt INC

Quality Engineer

Northfield, IL · On-site

$74K - $96K/yr

Ensure compliance with FDA and international quality regulations * Maintain Device Master Records ... Bachelor's degree in Engineering, Science, Mathematics, or related technical field. Thanks ...

Flex Ltd.

Quality Engineer

Manchester, CT · On-site

$72K - $93K/yr

Job Summary The Quality Engineer will be based Manchester, CT , reporting to Quality Manager. In ... ISO13485, ISO 14971, FDA * Hands-on experience with CAPA systems, nonconformance investigations ...

Flex

Quality Engineer

Manchester, CT

$72K - $93K/yr

Job Summary The Quality Engineer will be based Manchester, CT , reporting to Quality Manager. In ... ISO13485, ISO 14971, FDA * Hands-on experience with CAPA systems, nonconformance investigations ...

Intellectt INC

Quality Engineer

Westfield, MA · On-site

$75K - $97K/yr

Initiate and execute quality assurance activities aligned with FDA Quality System Regulations and ... Engineering experience * Experience in medical devices (preferred) OR pharma/electronics

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Flexible Quality Engineer Fda information

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How much do flexible quality engineer fda jobs pay per year?

As of Aug 8, 2026, the average yearly pay for flexible quality engineer fda in the United States is $84,039.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $93,000.00 per year, depending on experience, location, and employer.

What is the difference between Flexible Quality Engineer Fda vs Quality Assurance Specialist?

AspectFlexible Quality Engineer FdaQuality Assurance Specialist
CertificationsISO, FDA regulations, Six SigmaISO, FDA regulations, Six Sigma
Work EnvironmentManufacturing, biotech, medical devicesManufacturing, biotech, medical devices
Primary FocusDesign, development, and compliance of productsMonitoring, auditing, and ensuring quality standards

The Flexible Quality Engineer Fda and Quality Assurance Specialist roles share similar certifications and work environments, often within manufacturing and medical device industries. The main difference lies in their focus: the Flexible Quality Engineer Fda is involved in product design and compliance, while the Quality Assurance Specialist concentrates on monitoring and maintaining quality standards throughout production.

What cities are hiring for Flexible Quality Engineer Fda jobs? Cities with the most Flexible Quality Engineer Fda job openings:
What are the most commonly searched types of Quality Engineer Fda jobs? The most popular types of Quality Engineer Fda jobs are:
What states have the most Flexible Quality Engineer Fda jobs? States with the most job openings for Flexible Quality Engineer Fda jobs include:
Flexible Quality Engineer Fda jobs near you

Quality Engineer III / Sr. Quality Engineer

LanceSoft Inc

Redwood City, CA • On-site

$88K - $113K/yr

Contractor

Re-posted 25 days ago

Job description

Company Description

JOHNSON & JOHNSON / CALIBRA

Job Description
Title: Sr. Quality Engineer for Swing Shift
2. Supervisor: QA Manager
3. Location: Redwood City, CA
4. Purpose of Position:
Supports production of clinical devices and process development. Maintains compliance to Medical Device Directives (MDD), ISO 13485, and Quality System Regulations for Design Controls. Create protocols and reports for a device manufacturing and testing where needed. Perform specific data analysis and trending as required. Provide technical support to Manufacturing and R&D.
5. Essential Functions:
Assists in assuring that Good Manufacturing Practice requirements are met, including Design Control.
Performs review of production LHR and signoff as required.
Reviews currently manufacturing process documentation and records.
Works with Quality and Operations to maintain quality requirements in the support of clinical builds.
Develops and implements specific testing for existing and new products including supporting process validations.
Provides support to manufacturing inspection process development.
Researches and provides guidance to the design team regarding standards and regulations applicable to the development project.
Perform other duties in quality assurance as directed.
Works in accordance with quality system procedures.
6. Minimum Education: BS/BA in an Engineering discipline preferred, equivalent combination of education and work experience acceptable.
7. Minimum Experience: 5 years of experience in Quality Engineering in the medical device industry.
8. Licenses, Certifications, and Registrations: ASQ Certified Quality Engineer certification preferred.
9. Other Essential Knowledge, Skills, and Abilities:
Must have strong oral and written communication skills.
Strong knowledge in the use of manufacturing processes used in the medical device industry.
Strong knowledge of statistical data analysis.
Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO14971.
10. Working Environment:
Job duties are typically performed in an office environment. Overall duties require the ability to stand or sit for lengthy periods of time in a lab. Required duties include utilizing standard office equipment such as a computer, photocopier, and telephone, and reading and writing.
11. Travel (if any):
Some out of town travel be required for supplier interactions (anticipated to be 10% of time)
12. Personal Protective Equipment:
Latex/rubber/heat resistant gloves, UV eye protection, safety glasses, goggles, respirators, splash aprons, cleanroom gowning wear (smocks, head covers, beard covers, shoes covers)


Qualifications
 Minimum Education: BS/BA in an Engineering discipline preferred, equivalent combination of education and work experience acceptable.
 Minimum Experience: 5 years of experience in Quality Engineering in the medical device industry. Licenses, Certifications, and Registrations: ASQ Certified Quality Engineer certification preferred.
Other Essential Knowledge, Skills, and Abilities:
Must have strong oral and written communication skills.
Strong knowledge in the use of manufacturing processes used in the medical device industry.
Strong knowledge of statistical data analysis.
Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO14971.


Additional Information

9. Other Essential Knowledge, Skills, and Abilities:
Must have strong oral and written communication skills.
Strong knowledge in the use of manufacturing processes used in the medical device industry.
Strong knowledge of statistical data analysis.
Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO14971.

LanceSoft logo

About LanceSoft

Sourced by ZipRecruiter

Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Herndon, VA, US

Year founded

2000

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