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Quality Engineer Fda Jobs (NOW HIRING)

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 ...

LaborMax - Olive Branch, MS

Be Seen First

Quality Engineer

Olive Branch, MS · On-site

$85K - $100K/yr

Quality Engineer - Medical Device Manufacturing Location: Olive Branch, MS Job Type: Full-Time Join ... Maintain documentation in compliance with ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 1271, and ...

TeamSoft

Quality Engineer

Greer, SC · On-site

$50/hr

Quality Engineer Are you a Quality Engineer ready to take your career to new heights? We have an ... Responsible for ensuring compliance with regulatory standards (GMP, ISO, FDA) and customer ...

New

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 ...

Flotec

Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

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 ...

Zing! Recruiting

Quality Engineer

Greer, SC

Quality Engineer Are you a Quality Engineer ready to take your career to new heights? We have an ... Responsible for ensuring compliance with regulatory standards (GMP, ISO, FDA) and customer ...

New

Martech Medical Products

Quality Engineer

Harleysville, PA · On-site

$69K - $89K/yr

Quality Engineer Position Summary The Quality Engineer is responsible for ensuring product quality ... Maintain and improve the Quality Management System (QMS) in compliance with FDA 21 CFR Part 820 ...

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 ...

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 ...

Innovative Health

Quality Engineer

Scottsdale, AZ · On-site

$72K - $93K/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

Supplier Quality Engineer

San Diego, CA · On-site

Supplier Quality Engineer Location: Near San Diego, CA Job Summary: We are seeking a Supplier ... Support compliance with FDA 21 CFR Part 820 (QMSR) and ISO 13485 . * Prepare quality reports 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 ...

Natera

Quality Engineer

Austin, TX · Hybrid

$71K - $92K/yr

Quality Engineer supports the quality system processes of the Natera CLIA laboratories and ... Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA * Participate in the ...

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All JobsQuality Engineer Fda Jobs

Quality Engineer Fda information

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$45K

$84K

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How much do quality engineer fda jobs pay per year?

As of Aug 6, 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?

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 skills and qualifications are needed to be a quality engineer FDA?

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 does a Quality Engineer FDA do in the pharmaceutical industry?

A Quality Engineer FDA in the pharmaceutical industry ensures that products meet regulatory standards set by the FDA by developing and implementing quality systems, conducting audits, and reviewing documentation. They often work with validation processes, risk assessments, and compliance protocols to maintain product safety and efficacy. Certification in Good Manufacturing Practices (GMP) and knowledge of FDA regulations are typically required.

What challenges does a quality engineer FDA face 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 August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.

Supplier Quality Engineer

Intellectt INC

New Marlborough, MA • On-site

Contractor

Re-posted 19 days ago

Job description

Dear Job Seeker,

I hope you're doing well.

My name is Abida Khan, Technical Recruiter at Intellectt Inc. I am reaching out regarding an exciting opportunity for a Supplier Quality Engineer position with one of our prestigious Medical Device clients

We are seeking professionals with experience in Supplier Quality Engineering, FDA Remediation, CAPA, Root Cause Analysis, DFMEA/PFMEA, Supplier Controls, Risk Management, and Medical Device Quality Systems.

I would love to connect and discuss this opportunity in more detail. If you are interested, please share your updated resume at abida.khan@intellectt.com.

I look forward to hearing from you

Job Title: Supplier Quality Engineer

Locations: Massachusetts

Job Summary

We are seeking an experienced Supplier Quality Engineer to support FDA remediation activities within a leading Medical Device organization. The ideal candidate will have strong experience in supplier quality, CAPA investigations, risk management, FMEA, supplier controls, and FDA compliance.

Core Responsibilities

• Assess supplier risk and implement supplier quality improvements.
• Review and align DFMEA, PFMEA, and supplier manufacturing processes.
• Support FDA remediation and Warning Letter activities.
• Conduct supplier quality investigations and CAPA activities.
• Support IQ/OQ/PQ validation activities.
• Collaborate with suppliers to improve process capability and quality controls.

Required Qualifications

• 5+ years of Supplier Quality Engineering experience.
• Medical Device industry experience.
• FDA remediation or Warning Letter remediation experience.
• CAPA, Root Cause Analysis, FMEA, and Supplier Quality experience.