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Quality Engineer Fda Jobs (NOW HIRING)

Quality Engineer

Tempe, AZ · On-site

$69K - $89K/yr

Quality Engineer Location : Tempe, AZ Duration : 5 Months Total Hours/week : 40.00 1st Shift Client ... Good Manufacturing Practices, ISO, FDA). * Proven ability to develop solutions to a variety of ...

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 ...

Quality Engineer

Waltham, MA · On-site

$90K - $135K/yr

Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and EU MDR requirements. * Demonstrated problem solving skills and the ability to analyze complex situations and make sound decisions.

Quality Engineer

Whippany, NJ · On-site

$40 - $45/hr

OVERVIEW The Quality Engineer will support the aseptic manufacturing and quality systems for ... This role ensures compliance with applicable regulatory requirements including US FDA 21 CFR Parts ...

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 ...

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

Quality Engineer

Santa Cruz, CA · On-site

$83K - $107K/yr

The Product Quality Engineer is responsible for providing quality engineering support to the ... Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.

Quality Engineer

Santa Cruz, CA

$83K - $107K/yr

The Product Quality Engineer is responsible for providing quality engineering support to the ... Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.

Quality Engineer

Palo Alto, CA · On-site

$90K - $110K/yr

Ensure FDA and global compliance, manage registration, and maintain documentation. * CAPA & Quality ... Bachelor's degree preferably in engineering, and 0-2+ years in medical device quality engineering ...

Quality Engineer

Santa Cruz, CA

$83K - $107K/yr

The Product Quality Engineer is responsible for providing quality engineering support to the ... Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.

Quality Engineer

Brimfield, MA · On-site

$70K - $95K/yr

Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and ... Provides support to other quality engineers. * Performs other functions as required. The successful ...

Quality Engineer

Westford, MA · On-site

$74K - $96K/yr

S. 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 ...

Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and ... Provides support to other quality engineers. * Performs other functions as required. The successful ...

Quality Engineer

Brimfield, MA · On-site

$70K - $95K/yr

Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and ... Provides support to other quality engineers. * Performs other functions as required. The successful ...

Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and ... Provides support to other quality engineers. * Performs other functions as required. The successful ...

Principal Quality Engineer

Ontario, CA · On-site

$130K - $150K/yr

The Principal Quality Engineer will serve as a subject matter expert in regulatory compliance (e.g., ISO 13485, FDA QSR), validation strategy, and supplier quality, ensuring robust risk management ...

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 ...

Quality Engineer

Bethlehem, PA · On-site

$65K - $75K/yr

The Quality Engineer plays a key role in supporting the organization's Quality Management System ... This position supports compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and MDSAP requirements ...

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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:
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

millenniumsoft

Tempe, AZ • On-site

$69K - $89K/yr

Full-time

Posted 14 days ago


Job description

Position : Quality Engineer
Location : Tempe, AZ
Duration : 5 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Engineering
Level Of Experience: Mid-Level
Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
Job Description:
  • Responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant.
  • Ensure documentation and procedures are followed as required by internal Quality Policies and related FDA/GMP guidelines.
  • Conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
  • BS or BA in related field required with up to 2 years of experience, or MS with no experience required.
  • Typical degree in Mechanical or Electrical or Industrial or Biomedical Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
  • Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA).
  • Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
  • Capable of using Microsoft programs and ability to learn other systems.
  • Utilizing TRACKWISE software is an advantage.
  • Effective verbal and written communication skills.
  • The ability to work in teams and independently with minimal supervision to obtain results as required.
  • Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.