ZipRecruiter

Log In

1

Quality Engineer Fda Jobs (NOW HIRING)

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 ...

Cynet Systems

Quality Engineer II

Scarborough, ME · On-site

$73K - $94K/yr

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

Lancesoft

Quality Engineer II

Scarborough, ME · On-site

$35 - $42.09/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 ...

Balda C Brewer

Quality Engineer

Ontario, CA · On-site

$80K - $120K/yr

Quality Engineer supports all aspects of the Quality Management System, Product Realization and ... Working in a medical device or other FDA regulated industry. Comprehensive understanding of ISO ...

Intellectt INC

Supplier Quality Engineer

San Diego, CA · On-site

... • FDA & ISO 13485 Compliance • Supplier Quality Issue Resolution • Risk Assessment ... Engineering, Manufacturing & Purchasing Requirements: • Bachelor's Degree in Engineering or a ...

New

Intellectt INC

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 ...

Convergent Dental, Inc.

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.

MPE-Inc

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 ...

Fortive

Quality Engineer

Everett, WA

$79K - $102K/yr

Description: As a Quality Engineer on our Fluke Health Solutions Quality Assurance/Regulatory ... External : Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers.

Astrix Inc

Quality Engineer II

Irvine, CA · On-site

$77K - $99K/yr

... FDA, ISO 13485, and Quality System requirements Qualifications: • Bachelor's degree in Engineering required • 3+ years of quality engineering experience in a regulated industry • Medical device ...

Germfree Laboratories Inc

Quality Engineer

Ormond Beach, FL · On-site

$63K - $81K/yr

Quality Engineer · Department: Quality Engineering · Location: Ormond Beach, FL (USA) · ... Its products are engineered to support a range of customer and industry standards (cGMP / FDA 21 ...

New

Intellectt INC

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

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.

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.

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 ...

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.

Spectrum Staffing Services

Be Seen First

Quality Engineer

Raleigh, NC · On-site

$43 - $45/hr

Support, maintain, and improve the Quality Management System (QMS) in compliance with FDA, ISO ... Process engineering and document change requests while ensuring proper implementation and ...

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 ...

New

next page

Showing results 1-20

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 Jul 9, 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 July 2026, with employment types broken down into 95% Full Time, 2% Part Time, and 3% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.
Quality Engineer

Quality Engineer

Bradford Soap Works Inc

West Warwick, RI • On-site

$69K - $90K/yr

Full-time

Posted 7 days ago

Job description

Job Title: Quality Engineer

Reports to: Quality Operations Manager

Job Function:

The Quality Engineer supports quality systems and product quality for a personal care contract manufacturing operation. This role has no direct reports and works cross‑functionally with Operations, Engineering, R&D, and Customer Service to ensure compliance with customer, regulatory (ISO, FDA, Organic, etc.), and internal requirements. The Quality Engineer plays a key role in audits, root cause analysis, and customer complaint management while driving continuous improvement across the site.

Essential Duties and Responsibilities:

Quality Systems and Compliance

  • Support and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and applicable customer requirements.
  • Lead internal audits, customer audits, and third‑party audits; prepare documentation, support on‑site activities, and ensure timely closure of audit findings.
  • Assist with document control, SOP updates, and change management activities.
  • Support risk assessments, control plans, and quality metrics reporting.

Root Cause Analysis & Corrective Actions

  • Lead and facilitate root cause analysis using structured problem‑solving tools (e.g., 5 Whys, Fishbone, FMEA).
  • Develop, implement, and track corrective and preventive actions (CAPAs) to ensure effectiveness and sustainability.
  • Partner with Operations and Engineering to address quality issues, reduce defects, and improve process capability

Customer Complaint Management

  • Manage customer complaints from receipt through closure, including investigation, root cause analysis, corrective action development and implementation, and response preparation.
  • Coordinate cross‑functional investigations to ensure timely, accurate, and professional customer responses.
  • Identify complaint trends and drive systemic improvements to prevent recurrence.

Manufacturing & Process Support

  • Provide quality support to manufacturing operations, including deviation investigations and nonconformance management.
  • Support sampling, documentation, and shipment of raw materials, batch, and finished product samples to outside labs for testing.
  • Support new product introductions (NPI), validation protocols (IQ/OQ/PQ), and process changes and subsequent process change control from a quality perspective.
  • Review batch records, inspection data, and quality documentation as needed.

Continuous Improvement

  • Analyze quality data to identify trends, risks, and improvement opportunities.
  • Participate in Lean, Six Sigma, or other continuous improvement initiatives.
  • Promote a culture of quality, compliance, and accountability throughout the organization.

Minimum Knowledge, Skills and Abilities:

  • Bachelor’s degree in Engineering, Quality, Chemistry, or a related technical field.
  • 3+ years of quality engineering or quality assurance experience in a manufacturing environment.
  • Experience with audits, nonconformance investigations, customer complaint management, root cause analysis, CAPA development and implementation.
  • Working knowledge of GMP and quality management systems.
  • Strong analytical, organizational, and problem‑solving skills.
  • Effective written and verbal communication skills.
  • Preference for Lean, Six Sigma or quality certification.
  • Familiarity with regulatory compliance requirements applicable to certifications such as organic, Halal, naturals etc… would be desirable.

Physical & Work Environment:

  • Manufacturing environment with regular presence on the production floor.
  • Ability to sit, stand, walk, and occasionally lift up to 25 lbs.
  • Occasional travel for customer or supplier audits may be required.

Apply