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Flexible Quality Engineer Fda Jobs (NOW HIRING)

Ingersoll-Rand

Quality Engineer

Lincolnshire, IL · On-site

$60 - $80/hr

Quality Engineer Location: Lincolnshire, IL About Us Imagine a company with technology leadership ... Familiarity with FDA 21 CFR Part 820 and ISO 13485 requirements * Experience with electronic ...

Capstan Medical, Inc.

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.

Comar

Quality Engineer

Buena, NJ · On-site

$60 - $80/hr

Able to follow applicable requirements of FDA cGMP, ISO 13485, ISO 9001, ISO 14971, FDA 110/210/211 ... Quality Engineering. * Experience with Technical writing of reports, data analysis, customer ...

Capstan Medical, Inc.

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.

CYNET SYSTEMS

Quality Engineer II

Scarborough, ME · On-site

$45/hr

Working knowledge of FDA regulations, ISO standards, and quality systems. * Proven ability to collaborate cross-functionally with Engineering, Manufacturing, and Regulatory teams. * Strong analytical ...

Millstone Medical Outsourcing

Quality Engineer

Southaven, MS · On-site

$65K - $84K/yr

We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO ... The role of the Quality Engineer is to assist in the planning, executing, and finalizing projects ...

New

Capstan Medical, Inc.

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.

medplast

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 ...

Millstone Medical Outsourcing

Quality Engineer

Pearl, MS · On-site

$62K - $80K/yr

We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO ... The role of the Quality Engineer is to assist in the planning, executing, and finalizing projects ...

New

Millstone Medical Outsourcing

Quality Engineer

Gulfport, MS · On-site

$71K - $92K/yr

We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO ... The role of the Quality Engineer is to assist in the planning, executing, and finalizing projects ...

New

Abbott

Quality Engineer I

Temecula, CA · On-site

$35 - $40/hr

Support compliance with cGMP requirements, Good Documentation Practices (GDP), FDA Quality System ... Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter ...

Millstone Medical Outsourcing

Quality Engineer

Biloxi, MS · On-site

$64K - $82K/yr

We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO ... The role of the Quality Engineer is to assist in the planning, executing, and finalizing projects ...

New

Viant

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 ...

Millstone Medical Outsourcing

Quality Engineer

Meridian, MS · On-site

$70K - $91K/yr

We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO ... The role of the Quality Engineer is to assist in the planning, executing, and finalizing projects ...

New

Delcath Systems Inc

Quality Engineer

Queensbury, NY · On-site

$65K - $75K/yr

... FDA, ISO regulations and the Medical Device Directives/Regulations. The Quality Engineer provides QA support for the company by working with the Quality Assurance Manager to assure proper GMP ...

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All Jobswork remotely one day a week JobsFlexible Quality Engineer Fda Jobs

Flexible Quality Engineer Fda information

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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?

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What are the most commonly searched types of Quality Engineer Fda jobs?

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What states have the most Flexible Quality Engineer Fda jobs?

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

Flexible Quality Engineer Fda jobs near you

Quality Engineer II_US

Indotronix International Corporation

Columbia, MD • On-site

$70K - $91K/yr

Full-time

Posted 14 days ago

Job description

AI-Optimized Job Summary: Quality Engineer II (On-site, Columbia, MD)
Are you passionate about elevating product quality and compliance in a cutting-edge, regulated environment? Join our team in Columbia, MD as a Quality Engineer II and play a key role in safeguarding the efficacy and compliance of medical device manufacturing processes.
In this pivotal on-site position, you'll collaborate closely with engineering and operations teams to review critical documentation, manage preventive maintenance, and drive day-to-day Quality Assurance (QA) operations. Your expertise in GMP (Good Manufacturing Practice) and experience with Data Integrity will be instrumental as you facilitate change management, lead root cause investigations, and help ensure our products meet stringent FDA QMSR (21 CFR Part 820), ISO 13485, EUMDR, and CMDR standards. You'll support the full product lifecycle, from development and validation to commercialization, authoring and approving essential quality records, protocols, and SOPs.
Key Responsibilities:
- Lead and maintain the site's change management system, ensuring quality impact assessments and implementation of product/process changes.
- Conduct robust quality investigations-identify root causes, implement CAPAs, and maintain thorough documentation.
- Develop, review, and approve validation documents, quality records, and protocols supporting GxP manufacturing and development.
- Support critical control programs such as calibration, preventive maintenance, and environmental monitoring.
- Participate in internal/external audits and regulatory inspections (FDA, ISO, customer).
- Stay current with global regulatory standards and industry best practices.
- Analyze and report on quality data trends, supporting data-driven decision-making.
Qualifications:
- Bachelor's degree in Science or Engineering required; Master's preferred (experience may substitute for education).
- 2+ years in Quality Engineering within a GMP-controlled, regulated environment (medical device or pharma strongly preferred).
- Deep understanding of FDA QMSR (21 CFR 820), ISO 13485, EUMDR, and/or CMDR requirements.
- Demonstrated Data Integrity expertise is a major plus.
- Skilled in validation, change management, statistical analysis, and root cause investigations.
- Strong documentation, communication, and cross-functional teamwork abilities.
Why Join Us?
- Opportunity for contract extension and career growth.
- Be a vital contributor to quality-driven product development in a regulated, innovative field.
- Collaborate with top-tier professionals in engineering, operations, and regulatory compliance.
Ready to advance your Quality Engineering career and make a tangible impact on patient safety and product excellence? Apply now to join our Columbia, MD team!
Keywords: Quality Engineer, GMP, Data Integrity, Validation, Change Management, Medical Device, FDA QMSR, 21 CFR 820, ISO 13485, EUMDR, CMDR, Quality Assurance, CAPA, Root Cause Analysis, On-Site, Columbia MD
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About Indotronix

Sourced by ZipRecruiter

In 1986, Indotronix established itself in the staffing space. 22 years later, Avani entered the scene, offering consulting and technology development. Finally, in 2016, the two joined forces to begin delivering talent across all areas, from Staffing to Consulting to unique platform development.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Rochester, NY, US

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