ZipRecruiter

Log In

1

Quality Engineer Fda Jobs (NOW HIRING)

Advita Ortho

Sr. Quality Engineer

Gainesville, FL · On-site

$79K - $108K/yr

Sr. Quality Engineer Department: Quality Employment Type: Full Time Location: Gainesville, FL ... Lead quality activities for new product development, ensuring compliance with FDA, ISO, and design ...

Coloplast

Quality Engineer

Minneapolis, MN · On-site

$88K - $132K/yr

Provide quality engineering support to US Operations to ensure FDA/ISO compliance and act as first line support for quality issues. * Recommend and implement quality improvements and processes to ...

SEDAA

Quality Engineer

Westford, MA

$60K - $78K/yr

FDA, EUMDR and other requirements, as applicable. • Maintain positive and cooperative ... Quality Engineer Location: Santa Clara, CA (100% ON-SITE) ID# SEDAA __42840 PAY RANGE: 50K - 70K ...

Stefanini

Quality Engineer

Skaneateles Falls, NY · On-site +1

$77K - $100K/yr

Stefanini is looking for Quality Engineer in Skaneateles, NY (Hybrid/Remote) For quick Apply ... Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determine ...

Polyzen, LLC

Quality Engineer

Apex, NC · On-site

$69K - $89K/yr

The Quality Engineer develops, coordinates, and implements various activities related to the ... Supports FDA Inspections, Customer and Third-party Audits as required. * May perform internal or ...

Exactech

Sr. Quality Engineer

Gainesville, FL

$80K - $108K/yr

The Sr. Quality Engineer serves as the Quality owner for a defined orthopedic joint product ... Lead quality activities for new product development, ensuring compliance with FDA, ISO, and design ...

Intellectt INC

Quality Engineer

Chicago, IL · On-site

$74K - $95K/yr

Quality Engineer Location: Chicago, IL or Northfield, IL Duration: Longterm Job Summary The Quality ... Support FDA, ISO, and notified body audits or inspections. * Help prepare audit documents and fix ...

Polyzen LLC

Quality Engineer

Apex, NC · On-site

$69K - $89K/yr

The Quality Engineer develops, coordinates, and implements various activities related to the ... Supports FDA Inspections, Customer and Third-party Audits as required. * May perform internal or ...

coringroup

Quality Engineer

Raynham, MA · On-site

$65/hr

We are hiring a Quality Engineer to join our growing team in Raynham, MA in this on-site position ... within FDA and ISO regulations. This is accomplished by establishing, updating, and maintaining ...

Solesis

Quality Engineer

Apex, NC · On-site

$69K - $89K/yr

The Quality Engineer develops, coordinates, and implements various activities related to the ... Supports FDA Inspections, Customer and Third-party Audits as required. * May perform internal or ...

Remedy Robotics, Inc

Quality Engineer

San Francisco, CA · On-site

$84K - $109K/yr

Proven ability to author technical documentation that withstands regulatory (FDA) review and ... engineering work into compliant quality and regulatory records * Sound, risk-based judgment in ...

Abbott

Quality Engineer

Temecula, CA

$71K - $92K/yr

Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies ... Previous Quality engineering experience and demonstrated use of Quality tools/methodologies.

Abbott

Quality Engineer

Temecula, CA · On-site

$71K - $92K/yr

Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies ... Previous Quality engineering experience and demonstrated use of Quality tools/methodologies.

Abbott

Quality Engineer II

Atlanta, GA · On-site

$61K - $122K/yr

The Quality Engineer II partners with Manufacturing, Operations, Engineering, and Quality teams to ... Ensure compliance with FDA, ISO 13485, MDR, and company quality system requirements. * Maintain ...

next page

Showing results 1-20

People also search for

All JobsQuality Engineer Fda Jobs

Quality Engineer Fda information

See salary details

$45K

$84K

$119K

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.

Sr. Quality Engineer

Advita Ortho

Gainesville, FL • On-site

$79K - $108K/yr

Full-time

Posted 11 days ago

Job description

Sr. Quality Engineer
Department: Quality
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Manager, Quality Engineering
Description
The Sr. Quality Engineer serves as the Quality owner for a defined orthopedic joint product portfolio (e.g., Knee, Hip, Shoulder), providing end-to-end quality engineering support across the full product lifecycle. This role ensures quality, regulatory compliance, and risk management from design through post-market support.
Key Responsibilities
  • Serve as the Quality Engineering lead for a designated product line, ensuring product quality and compliance across the full lifecycle-from development through post-market support
  • Lead quality activities for new product development, ensuring compliance with FDA, ISO, and design control requirements
  • Partner with R&D to translate user needs into quality requirements, identify critical-to-quality characteristics, and support design reviews
  • Drive risk management activities, including DFMEA, hazard analysis, and lifecycle risk file maintenance (ISO 14971)
  • Lead verification & validation strategy, execution, and documentation
  • Support design transfer and product launch, including inspection methods, control strategies, and process validation (IQ/OQ/PQ)
  • Collaborate with Supply Chain on supplier qualification and readiness
  • Act as the Quality lead for sustaining engineering activities, including investigation and resolution of nonconformances, CAPAs, and customer complaints
  • Analyze product and field performance data to identify trends, risks, and improvement opportunities
  • Lead change control activities to ensure continued product quality and compliance
  • Drive root cause analysis and continuous improvement initiatives using a risk-based approach
  • Serve as a cross-functional Quality SME, partnering with R&D, Manufacturing, Regulatory, Clinical, and Marketing teams
  • Support audits and provide mentorship or technical guidance to junior engineers

Skills Knowledge and Expertise
Education:
  • Bachelor's Degree in Engineering required; advanced degree preferred

Experience:
  • 5+ years in medical device or highly regulated industry
  • Demonstrated experience supporting full product lifecycle (design → launch → post-market)
  • Experience in orthopedic implants or joint systems strongly preferred

Functional/Technical Knowledge, Skills and Abilities Required:
  • Deep understanding of:
    • Design controls and lifecycle management
    • Risk management (ISO 14971)
    • Statistical analysis and sampling methods
  • Working knowledge of:
    • FDA 21 CFR Part 820
    • ISO 13485 and global regulatory requirements
  • Experience with
    • Verification & Validation
    • CAPA and root cause analysis
    • Change control systems
  • Familiarity with GD&T and inspection systems preferred

Apply