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Quality Engineer Fda Jobs (NOW HIRING)

Kelly Services

Quality Engineer

Austin, TX

$71K - $92K/yr

Contract Quality Engineer (FDA-Focused, Manufacturing Transfer) (Austin, Texas) Our client is Austin, Texas has an urgent need for a Contract Quality Engineer to assist team transferring Quality and ...

Kelly Services

Quality Engineer

Austin, TX

$71K - $92K/yr

Contract Quality Engineer (FDA-Focused, Manufacturing Transfer) (Austin, Texas) Our client is Austin, Texas has an urgent need for a Contract Quality Engineer to assist team transferring Quality and ...

Stark Pharma Solutions Inc

Quality Engineer

Cambridge, MA · On-site

$78K - $101K/yr

Quality Engineer Location: Cambridge , MA Industry: Medical Device / Pharmaceutical Job Summary We ... Support Quality Management System (QMS) activities and ensure compliance with FDA, cGMP, and ISO ...

Aptyx

Quality Engineer

Taunton, MA · On-site

$73K - $95K/yr

Quality Engineer Location: Taunton, MA Department: Quality Reports to: Quality Manager Position ... Regulatory & QMS Compliance * Assist in ensuring compliance with ISO 13485, and FDA 21 CFR Part 820 ...

Comar Engineering Services

Quality Engineer

Buena, NJ · On-site

$71K - $92K/yr

QUALITY ENGINEER At Comar, we're passionate about progress and finding opportunity in new ideas. In ... Food & Drug Administration (FDA), International Standards Organization (ISO), medical device and ...

Iridex Corporation

Quality Engineer

Mountain View, CA · On-site

$112K - $120K/yr

Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...

Iridex Corporation

Quality Engineer

Mountain View, CA · On-site

$112K - $120K/yr

Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...

Theragenics Corp

Quality Engineer

Attleboro Falls, MA · On-site

$97K - $115K/yr

The Quality Engineer will collaborate cross-functionally with Engineering, Manufacturing, and ... Ensure compliance with applicable regulatory and industry standards, including FDA 21 CFR Part 820 ...

Theragenics Corp

Quality Engineer

Attleboro Falls, MA · On-site

$97K - $115K/yr

The Quality Engineer will collaborate cross-functionally with Engineering, Manufacturing, and ... Ensure compliance with applicable regulatory and industry standards, including FDA 21 CFR Part 820 ...

Smiths Machine

Quality Engineer

Huntingdon Valley, PA · On-site

$70K - $91K/yr

Ensure compliance with ISO 13485 and FDA quality system regulations * Evaluate design and process changes for impact to Design History Files (DHF) and lead gap closure activities * Develop and ...

Excel Engineering Inc

Quality Engineer (MN)

Moundsview, MN · On-site

$80K - $120K/yr

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

avalign

Quality Engineer

Schaumburg, IL

$70K - $91K/yr

... FDA Quality System Regulation and ISO 13485. * Supports operations and engineering teams to ensure ... the Material Review Board process is followed. * Provides ongoing quality engineering support to ...

Bradford Soap Works Inc

Quality Engineer

West Warwick, RI · On-site

$69K - $90K/yr

Job Title: Quality Engineer Reports to: Quality Operations Manager Job Function: The Quality ... Support and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and ...

Bradford Soap Works Inc

Quality Engineer

West Warwick, RI · On-site

$69K - $90K/yr

Job Title: Quality Engineer Reports to: Quality Operations Manager Job Function: The Quality ... Support and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and ...

ARCH Global Precision

Quality Engineer

Huntingdon Valley, PA · On-site

$70K - $91K/yr

Ensure compliance with ISO 13485 and FDA quality system regulations * Evaluate design and process changes for impact to Design History Files (DHF) and lead gap closure activities * Develop and ...

Balda C Brewer

Quality Engineer

Ontario, CA · On-site

$80K - $120K/yr

Quality Engineer supports all aspects of the Quality Management System, Product Realization and ... Working in a medical device or other FDA regulated industry. Comprehensive understanding of ISO ...

MPE-Inc

Quality Engineer

Milwaukee, WI · On-site

$85K - $95K/yr

We are looking for a quality engineer to monitor and improve the quality of our operational ... FDA, GMP, ISO 9001 and ISO 13485. • Knowledge of PFMEA and PPAP processes.

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Quality Engineer Fda information

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How much do quality engineer fda jobs pay per year?

As of Jun 18, 2026, the average yearly pay for 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 a Quality Engineer FDA job?

A Quality Engineer FDA ensures that products and processes comply with FDA regulations and quality standards in industries like medical devices, pharmaceuticals, or biotech. They develop and implement quality systems, conduct audits, and support regulatory filings. Their role also includes investigating defects, implementing corrective actions, and collaborating with cross-functional teams to maintain compliance and improve quality.

What are the key skills and qualifications needed to thrive in the Quality Engineer Fda position, and why are they important?

A Quality Engineer FDA typically requires a background in engineering or life sciences, in-depth knowledge of FDA regulations (such as cGMP and 21 CFR Part 820), and experience with quality systems management. Familiarity with tools like CAPA (Corrective and Preventive Action), Risk Management, document control software, and certifications such as ASQ Certified Quality Engineer (CQE) are highly valued. Strong attention to detail, problem-solving skills, and the ability to communicate clearly across departments are crucial soft skills. These competencies ensure compliance with regulatory standards, reduce risk, and support the delivery of safe, effective products in regulated industries.

What are some typical challenges a Quality Engineer FDA faces in their daily work?

Quality Engineers working with FDA-regulated products often navigate complex regulatory requirements and must ensure strict adherence to quality protocols. They may face challenges such as addressing audit findings, implementing corrective actions quickly, and keeping up with evolving compliance standards. Collaboration across cross-functional teams—like manufacturing, regulatory affairs, and R&D—is vital to resolve issues and maintain consistent documentation. Successfully overcoming these challenges helps maintain product quality and reduces the risk of regulatory citations, positioning you as a valuable asset to your organization.

More about Quality Engineer Fda jobs
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 Quality Engineer Fda jobs? States with the most job openings for Quality Engineer Fda jobs include:
What job categories do people searching Quality Engineer Fda jobs look for? The top searched job categories for Quality Engineer Fda jobs are:
Quality Engineer Fda jobs near you
Infographic showing various Quality Engineer Fda job openings in the United States as of June 2026, with employment types broken down into 43% Full Time, 56% Part Time, and 1% Temporary. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.
Quality Engineer

Quality Engineer

Kelly Services

Austin, TX

$71K - $92K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 14 days ago

Job description

Contract Quality Engineer (FDA-Focused, Manufacturing Transfer)
(Austin, Texas)
Our client is Austin, Texas has an urgent need for a Contract Quality Engineer to assist team transferring Quality and Training documentation to a new facility.  This position is a Contract without an end date, the right motivated candidate will be encouraged, groomed for Direct Hire. 
The Contract Quality Engineer will provide technical and quality support for manufacturing operations within an FDA-regulated, ISO 13485 medical device environment. The role primarily focuses on supporting the transfer of manufacturing processes, quality systems, and training certifications to a new site. Operational excellence and FDA compliance are top priorities.  Experience reviewing and approving engineering change orders, nonconformances, CAPAs essential.
SUMMARY:
Working with Operations, Manufacturing and Engineering team, the Quality Engineer will be responsible for supporting and maintaining quality assurance activities within an In Vitro Diagnostics (IVD) manufacturing and development environment. This role ensures compliance with applicable regulatory requirements, including U.S. Food and Drug Administration regulations (21 CFR Part 820), ISO 13485, and other global standards governing medical devices and diagnostic products.
Quality Engineers apply technical knowledge to support product lifecycle processes, including design controls, risk management, process validation, and production quality. This role partners cross-functionally with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to ensure product quality and continuous improvement.
Key Responsibilities:
Assist in transferring manufacturing operations, quality processes, and documentation (including device history records and SOPs) to a new site.
Prioritize FDA regulatory requirements and maintain alignment with FDA QSR (21 CFR 820), ISO 13485, and similar standards in all quality and operational activities.
Develop and revise device history records, work instructions, validation protocols, and training certification documents for the new site.
Collaborate closely with R&D, operations, manufacturing, regulatory, and quality teams to execute transfer goals.
Support Design & Site Transfer (DSR) activities and facilitate effective onsite training.
Update training documentation and participate in internal audits as-needed during the transition.
Maintain accurate records, apply exceptional technical writing skills, and manage risk throughout the process.
Qualifications:
Bachelor’s degree in life sciences, engineering, or related field preferred.
2–10 years of quality assurance experience in medical device, diagnostic, or biotechnology industry with proven FDA experience.
Strong knowledge of FDA QSR (21 CFR 820), ISO 13485, design control, CAPA, validation, and quality documentation.
Experience in manufacturing site transfers, device history record development, and training certification documentation.
Excellent skills in data analysis, risk management, deviation handling, technical writing, and audit support.
Strong communication and teamwork abilities; attention to detail required.
Able to prioritize operations and regulatory compliance over job titles or manufacturing-only experience.
Comfortable working in large teams; leadership of the entire transfer is not expected.
About our Client:
Client is a global leader in diagnostic solutions, combining over 50 years of scientific and technological innovation to develop trusted diagnostic assays and instruments. Our products are used worldwide to improve patient care and clinical outcomes.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.

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