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Director Quality Engineer Fda Jobs (NOW HIRING)

Bradford Soap Works Inc

Quality Engineer

West Warwick, RI · On-site

$69K - $90K/yr

This role has no direct reports and works cross‑functionally with Operations, Engineering, R&D, ... Support and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and ...

Stark Pharma Solutions Inc

Quality Engineer

Newark, NJ · On-site

$75K - $97K/yr

Quality Engineer Location: New Jersey Duration: Long Term Position Overview We are seeking an ... This role will focus on ensuring compliance with FDA regulations, cGMP requirements, quality system ...

Masimo

Director, Quality Systems

Irvine, CA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Director partners cross-functionally with Quality, Regulatory, Engineering, Operations ... FDA 21 CFR Part 803 and 806 * ISO 13485 * EU MDR * MDSAP * Risk-based quality methodologies

Masimo

Director, Quality Systems

Irvine, CA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Director partners cross-functionally with Quality, Regulatory, Engineering, Operations ... FDA 21 CFR Part 803 and 806 * ISO 13485 * EU MDR * MDSAP * Risk-based quality methodologies

Flotec

Be Seen First

Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

  • Medical

  • Dental

  • Vision

Quality Engineer - Medical Device Manufacturing Company Overview Flotec is an Indianapolis-based ... Support and maintain compliance with ISO 13485, FDA QSR, and applicable medical device regulatory ...

Imperative Care

Director Quality Assurance

Campbell, CA · On-site

  • Medical

  • Retirement

  • PTO

Bachelor's degree in engineering or related discipline and a minimum of 10 years of progressive ... Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO ...

Danaher Corporation

Principal AI Quality Engineer

Vista, CA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

This position reports to the Director, Quality Assurance and Regulatory Compliance and is part of ... Support global regulatory submissions, such as FDA pre-subs, 510(k), and IVDR CE, while driving AI ...

Excel Engineering, Inc.

Quality Engineer (MN)

Moundsview, MN · On-site

$80K - $120K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Description Quality Engineer (MN) Full-time Mounds View, MN Description Excel Engineering is ... FDA 21 CFR Parts 11, 210/211, 820 (QMSR) * ISO 13485, ISO 9001 (as applicable) * EU MDR/IVDR and EU ...

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 ... Director of Quality and Regulatory ABOUT CONVERGENT DENTAL: Convergent Dental, Inc. is a privately ...

Imperative Care

Director Quality Assurance

Campbell, CA · On-site

$234K/yr

  • Medical

  • Retirement

  • PTO

Bachelor's degree in engineering or related discipline and a minimum of 10 years of progressive ... Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO ...

Danaher

Principal AI Quality Engineer

Vista, CA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

This position reports to the Director, Quality Assurance and Regulatory Compliance and is part of ... Support global regulatory submissions, such as FDA pre-subs, 510(k), and IVDR CE, while driving AI ...

Danaher

Principal AI Quality Engineer

Vista, CA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

This position reports to the Director, Quality Assurance and Regulatory Compliance and is part of ... Support global regulatory submissions, such as FDA pre subs, 510(k), and IVDR CE, while driving AI ...

Treace

Quality Engineer

Ponte Vedra, FL

$65K - $84K/yr

The Quality Engineer (QE) will be responsible for management and execution of assigned quality ... The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment ...

Treace

Quality Engineer

Ponte Vedra, FL

$65K - $84K/yr

The Quality Engineer (QE) will be responsible for management and execution of assigned quality ... The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment ...

Treace

Quality Engineer

Ponte Vedra, FL · On-site

$65K - $84K/yr

The Quality Engineer (QE) will be responsible for management and execution of assigned quality ... The QE shall have prior experience working within an FDA compliant Title 21 section 820 environment ...

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Director Quality Engineer Fda information

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$45K

$84K

$119K

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

As of Aug 18, 2026, the average yearly pay for director 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 Director Quality Engineer Fda vs Quality Engineer Fda?

AspectDirector Quality Engineer FdaQuality Engineer Fda
CredentialsTypically requires a Bachelor's degree in Engineering or Life Sciences, with certifications like ASQ CQE or ISO auditorRequires similar degrees and certifications, often entry to mid-level
Work EnvironmentLeads quality teams, oversees compliance, and strategic planning in manufacturing or biotech settingsPerforms hands-on quality testing, inspections, and process improvements
Industry UsageCommonly used in regulated industries like pharmaceuticals, biotech, and medical devicesUsed across manufacturing, biotech, and pharmaceutical companies for quality assurance

The main difference is that the Director Quality Engineer Fda holds a leadership role with strategic responsibilities, overseeing quality systems and compliance, while the Quality Engineer Fda focuses on operational quality tasks and testing. Both roles require similar credentials but differ in scope and seniority.

What cities are hiring for Director Quality Engineer Fda jobs?

Cities with the most Director 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 Director Quality Engineer Fda jobs?

States with the most job openings for Director Quality Engineer Fda jobs include:

Director Quality Engineer Fda jobs near you
Infographic showing various Director Quality Engineer Fda job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.

Quality Engineer III / Sr. Quality Engineer

LanceSoft Inc

Redwood City, CA

$88K - $113K/yr

Contractor

Re-posted 5 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

Social media

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