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Quality Engineer Fda Jobs (NOW HIRING)

LotusBakeries

Quality Engineer

Mebane, NC · On-site

$62K - $80K/yr

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 ...

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 ...

medplast

Quality Engineer

Brimfield, MA

$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 ...

Actalent

Quality Engineer

Carlsbad, CA · On-site

$35 - $48/hr

Familiarity with quality systems and applicable regulations, including FDA and ISO standards ... Ability to interpret engineering drawings and technical documentation * Strong analytical, problem ...

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 ...

Balda C Brewer

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 ...

Strive Pharmacy

Quality Engineer

Alachua, FL · On-site

$100K - $110K/yr

The Quality Engineer will partner and collaborate with the QA and Engineering teams to ensure that ... Ensure validation activities comply with cGMP, FDA regulations, ISO standards, and internal quality ...

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 ...

LotusBakeries

Quality Engineer

Mebane, NC · On-site

$62K - $80K/yr

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 ...

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 ...

Comfort Medical

Quality Engineer

Minneapolis, MN

$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 ...

Actalent

Quality Engineer

Minneapolis, MN · On-site

$43 - $53/hr

Quality Engineer - Post-Market Surveillance & Product Reliability Drive product quality and patient ... Ensure compliance with FDA regulations, ISO standards, and applicable medical device requirements.

Electrolit Manufacturing

Quality Engineer

Waco, TX

$63K - $82K/yr

The Quality Engineer will report to the Quality Manager. This position will work with sensitive ... Maintain and support Scheduled Process filings (FDA Form 2541) in coordination with Process ...

Electrolit Manufacturing USA Inc

Quality Engineer

Waco, TX · On-site

$63K - $82K/yr

The Quality Engineer will report to the Quality Manager. This position will work with sensitive ... Ensure compliance with FDA LACF regulations (21 CFR Part 113) and related food safety requirements.

Electrolit Manufacturing

Be Seen First

Quality Engineer

Waco, TX · On-site

$90K/yr

The Quality Engineer will report to the Quality Manager. This position will work with sensitive ... Ensure compliance with FDA LACF regulations (21 CFR Part 113) and related food safety requirements.

Enovis

Design Quality Engineer

Carlsbad, CA · On-site

This position will be responsible to assure product designs meet our compliance with FDA ... Quality Engineering Responsibilities may include: * Support, Review and Approve Design ...

Enovis

Design Quality Engineer

Carlsbad, CA · On-site

This position will be responsible to assure product designs meet our compliance with FDA ... Quality Engineering Responsibilities may include: * Support, Review and Approve Design ...

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Quality Engineer Fda information

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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

LotusBakeries

Mebane, NC • On-site

$62K - $80K/yr

Full-time

Posted 11 days ago

Job description

The Quality Engineer is responsible for leading daily quality assurance activities on the production floor, ensuring consistent execution of food safety, GMP, and product quality standards. This role manages routine testing and verification activities and supports issue resolution to maintain compliance with regulatory and customer requirements.
The Quality Engineer reports to the quality manager and plays a hands-on role in maintaining audit readiness, ensuring product integrity, and reinforcing a culture of "Quality Always" throughout the facility.
This position is fully onsite at the Lotus Bakeries' Mebane Plant and follows a 12-hour, 2-2-3 shift schedule.
Quality Management System (QMS) Support
  • Support the Quality Manager in maintaining and continuously improving the site Quality Management System.
  • Ensure that procedures, forms, and work instructions are current, controlled, and properly implemented on the production floor.
  • Assist in document reviews, updates, and change control processes.
  • Verify that quality records are complete, accurate, and compliant with regulatory and audit requirements.
  • Help identify gaps or improvement opportunities within QMS programs, contributing to corrective and preventive actions.

Daily Quality Operations
  • Supervise daily quality assurance activities across fabrication, packaging, and sanitation operations.
  • Provide real-time leadership on the plant floor to ensure adherence to GMPs, hygiene practices, and food safety standards, supporting production supervisors
  • Monitor process controls, CCPs, and CPs; escalate deviations promptly and support timely resolution.
  • Deliver GMP, hygiene, and product quality training to operators and new employees.

Testing, Inspection, and Verification
  • Oversee in-process checks, finished product testing, and environmental monitoring.
  • Ensure testing procedures, sampling plans, and documentation meet regulatory, customer, and internal standards.
  • Troubleshoot quality or analytical issues and escalate technical matters.

GMP, Food Safety, and Compliance
  • Conduct routine GMP, sanitation, and process audits to verify compliance with company policies and certification requirements.
  • Support execution of food safety & regulatory compliance programs at the room-by-room, line-by-line level.
  • Maintain audit-ready documentation, ensuring accuracy and completeness.

Nonconformance and Issue Management
  • Lead initial investigations for nonconformances, process deviations, or quality defects.
  • Perform data collection, assist with root cause analysis, and support CAPA actions.
  • Communicate quality concerns clearly to production teams and help drive corrective actions.

Cross-Functional Support
  • Partner closely with Production, Sanitation, Maintenance, Engineering, and Supply Chain to address quality issues and support continuous improvement.
  • Serve as the on-shift quality resource for operational troubleshooting and decision-making.

Education (degree): Bachelor's degree in food science, food technology, chemistry, biology, or engineering preferred
Specific knowledge:
  • HACCP (certification desired)
  • SQF or BRC
  • FSMA/FDA requirements
  • Global Food Safety Initiative requirements
  • Good Manufacturing Practices (GMP)
  • Regulatory audits (FDA, BRC, third-party)
  • Root cause analysis
  • ASQ Certified Quality Engineer (CQE) strongly desired

Experience:
  • 0-2 years of experience (food industry or related environment)
  • Familiarity with packaging lines, bakery processing equipment, and sanitation processes
  • Sanitation Standard Operating Procedures and corrective action plans (CAPAs)
  • Experience with International Featured Standards is a plus
  • Data analysis and quality metrics
  • Quality Management Systems

Language:
  • English (verbal and written, required)
  • Spanish (conversational preferred but not required)

Personal competences:
  • Have continuous improvement mentality
  • Be highly quality-oriented
  • Be able to concentrate on details for an extended period of time

Demonstrate Team Spirit, Open Dialogue, Passion
Ons aanbod
  • De kans om mee te bouwen aan een groeiende, internationale omgeving
  • Deel uitmaken van een ambitieus en gedreven team vol talenten
  • Veel leer- en groeikansen in de wereld van Category Management
  • Nauwe samenwerkingen met verschillende stakeholders in de groep
  • Een bedrijfscultuur waar passie, team spirit en open dialoog de belangrijkste drijfveren zijn
  • Een aantrekkelijk salarispakket, inclusief extralegale voordelen
  • En uiteraard: elke dag koekjes

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