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Flexible Quality Engineer Fda Jobs (NOW HIRING)

Quality Engineer

Dartmouth, MA · On-site

$100 - $125/hr

Understanding of GMP, FDA and SOP standards, guidelines, and regulatory requirements. * Ability to ... Quality Engineering. #J-18808-Ljbffr

New

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 ...

Quality Manufacturing Engineer

Phillipsburg, NJ · On-site

$68K - $88K/yr

Title- Quality Engineer Location: Phillipsburg, NJ - Onsite Job Summary We are seeking a Quality ... Ensure compliance with cGMP, ISO 9000, FDA, ICHQ7, and IPEC requirements. * Participate in internal ...

Quality Engineer III

Marietta, OH · On-site

$56K - $73K/yr

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Associate's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...

Quality Engineer

Waltham, MA · On-site

$90K - $135K/yr

Ensure compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part ... Flexible work from home options available. Compensation: $90,000.00 - $135,000.00 per year We are ...

Quality Engineer

Milwaukee, WI · On-site

$74K - $95K/yr

Ensure assigned quality engineering activities comply with ISO 13485, applicable FDA/QMS requirements, customer requirements, and MPE quality system procedures. * Review drawings, specifications ...

Quality Engineer

Manchester, CT · On-site

$72K - $93K/yr

Lead quality engineering activities throughout the product lifecycle, including process and ... ISO13485, ISO 14971, FDA * Hands-on experience with CAPA systems, nonconformance investigations ...

Quality Engineer

Manchester, CT · On-site

$72K - $93K/yr

Lead quality engineering activities throughout the product lifecycle, including process and ... ISO13485, ISO 14971, FDA * Hands-on experience with CAPA systems, nonconformance investigations ...

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

Mebane, NC · On-site

$60 - $80/hr

The Quality Engineer is responsible for leading daily quality assurance activities on the ... SQF or BRC * FSMA/FDA requirements * Global Food Safety Initiative requirements * Good ...

Quality Engineer

Cincinnati, OH · On-site

$50 - $60/hr

Quality Engineer Pay Rate: $50-60/hr Duration: 24-month contract Location: Cincinnati, OH Zip Code ... FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root ...

The NPD Quality Engineer is responsible to plan and coordinate quality engineering activities for ... ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable), EU/MDR. Responsibilities:

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Flexible Quality Engineer Fda information

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$84K

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

As of Sep 7, 2026, the average yearly pay for flexible 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 Flexible Quality Engineer Fda vs Quality Assurance Specialist?

AspectFlexible Quality Engineer FdaQuality Assurance Specialist
CertificationsISO, FDA regulations, Six SigmaISO, FDA regulations, Six Sigma
Work EnvironmentManufacturing, biotech, medical devicesManufacturing, biotech, medical devices
Primary FocusDesign, development, and compliance of productsMonitoring, auditing, and ensuring quality standards

The Flexible Quality Engineer Fda and Quality Assurance Specialist roles share similar certifications and work environments, often within manufacturing and medical device industries. The main difference lies in their focus: the Flexible Quality Engineer Fda is involved in product design and compliance, while the Quality Assurance Specialist concentrates on monitoring and maintaining quality standards throughout production.

What cities are hiring for Flexible Quality Engineer Fda jobs?

Cities with the most Flexible 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 Flexible Quality Engineer Fda jobs?

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

Quality Engineer

Socket.dev

Dartmouth, MA • On-site

$100 - $125/hr

Other

Posted 3 days ago

New


Job description

Job Summary

The Quality Engineer leads and uses Quality & Process Engineering principles, tools and practices to develop and optimize systems, and ensure processes are aligned with the overall business and quality vision of Tegra Medical. The individual must be capable of working independently and in a team setting supporting the Quality and Operations groups.

Role and Responsibilities
  • Develop and implement company quality policies, initiatives, and procedures of the Quality Management System and ensure compliance with US – CFR 21 part 820 (FDA QSR, GMP), ISO 13485.
  • Lead or support teams to investigate internal, supplier / external manufacturing quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA.
  • Lead the preparation of validation and qualification protocols and support the execution of supplier and external manufacturing process /product qualifications & validations (IQ, OQ, PQ) projects.
  • Management of Supplier Change Notifications with suppliers and external manufacturers.
  • Participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvements.
  • Ensures appropriate metrics/ Key Performance Indicators are defined, measured and analyzed to ensure process compliance and continuous improvement opportunities and follow up of product performance.
  • Provide or lead general engineering support to define in-process inspection & incoming inspection requirements.
  • Evaluates process critical quality parameters and updates specifications and protocols.
  • Additional duties and responsibilities as assigned by Supervisor.
Qualifications
  • ASQ CQE/CQA Preferred
  • Lean Six Sigma training (Green Belt and Black Belt) desired
  • Strong engineering skills, problem analysis/solving.
  • Excellent written and oral communication skills.
  • Understanding of GMP, FDA and SOP standards, guidelines, and regulatory requirements.
  • Ability to work in a fast paced manufacturing environment while managing multiple projects.
  • Strong engineering skills with working knowledge of the following: Process validation and verification activities. (IQ, OQ, PQ, PPQ).
  • Risk analysis techniques, which include PFMEA (Process Failure Modes and Effects Analysis). Manufacturing Control Plans and Flow Plans.
  • Blue print & GD&T reading.
  • Problem solving techniques including root cause analysis, and cause and effect analysis.
  • Proficiency with Microsoft Office products (Word, Excel, Project, PowerPoint) and Minitab.
  • Hands-on experience in the manufacturing, quality & process disciplines.
Education Requirements

A minimum B.S. in an engineering discipline or associates degree and equivalent experience of 5 years of in Quality Engineering.

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