Quality Engineer

Actalent; United States; Remote; USD 55,000 - 69,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan – Pre-tax and R

Life Insurance (Voluntary)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave

Job summary

Actalent is seeking a Quality Engineer with at least 2 years in medical device manufacturing to support a sustainability initiative while maintaining FDA compliance. You will collaborate with Quality, Manufacturing, Engineering, Supply Chain, and Sustainability teams to drive process improvements and environmentally responsible solutions.

Qualifications include a degree in engineering and 2+ years in quality engineering, with knowledge of 21 CFR 820, GMP, CAPA, RCA, and risk management.

Qualifications

• Bachelor's Degree in Engineering, Quality Engineering, Industrial Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• Minimum of 2 years of Quality Engineering experience in Medical Device Manufacturing.
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, Root Cause Analysis methodologies, CAPA processes, and Risk Management principles.
• Experience supporting manufacturing process improvements.
• Strong analytical, documentation, and problem-solving skills.
• Proficiency with Microsoft Office Suite and quality data analysis tools.

Responsibilities

• Maintain compliance with FDA QSR (21 CFR Part 820) and internal standards.
• Evaluate sustainability-related changes to processes, materials, and suppliers.
• Conduct risk assessments using FMEA, Fault Tree Analysis, and Hazard Analysis.
• Support CAPA investigations and corrective actions for quality and environmental projects.
• Participate in audits, regulatory inspections, and supplier assessments.
• Collaborate with cross-functional teams to reduce waste and optimize materials and energy.
• Analyze processes to reduce environmental impact while ensuring quality and compliance.
• Assist in material substitutions, packaging optimization, recycling, and carbon footprint efforts.
• Track sustainability metrics and prepare leadership reports.
• Utilize Lean and Six Sigma tools to drive improvements.
• Analyze production and quality data to identify trends and non-conformances.
• Develop and execute IQ/OQ/PQ validation activities for process changes.
• Work with Supplier Quality and Procurement on environmentally preferred suppliers.
• Review supplier documentation and support qualifications.
• Create and maintain quality documentation and validation records.
• Present updates and sustainability results to management.

Skills

Quality Engineering

FDA 21 CFR 820 knowledge

CAPA & RCA

Risk Management

Lean Six Sigma

Education

Bachelor's Degree in Engineering or related field

Tools

Microsoft Office

Excel

Job description

Job Title: Quality Engineer

Job Description

We are seeking a motivated and detail-oriented Quality Engineer with a minimum of 2 years of experience in medical device manufacturing to support a strategic sustainability initiative focused on reducing environmental impact while maintaining compliance with quality and regulatory requirements. This individual will partner with Quality, Manufacturing, Engineering, Supply Chain, and Sustainability teams to implement environmentally responsible solutions, improve manufacturing processes, and ensure continued adherence to FDA and applicable regulatory standards. The ideal candidate will possess a strong understanding of quality systems, risk management, continuous improvement methodologies, and manufacturing processes within highly regulated medical device environments.

Responsibilities

• Support and maintain compliance with FDA Quality System Regulations (21 CFR Part 820) and internal quality standards.
• Evaluate sustainability-related changes to manufacturing processes, materials, and suppliers through established change control procedures.
• Conduct risk assessments using tools such as FMEA, Fault Tree Analysis, and Hazard Analysis to assess impacts associated with sustainability initiatives.
• Support CAPA investigations and corrective actions related to quality, manufacturing, and environmental improvement projects.
• Participate in internal and external audits, regulatory inspections, and supplier assessments.
• Collaborate with cross-functional teams to identify opportunities for waste reduction, material optimization, energy efficiency, and sustainable manufacturing practices.
• Analyze manufacturing processes to reduce environmental impact while maintaining product quality and regulatory compliance.
• Support initiatives involving material substitutions, packaging optimization, recycling and waste reduction programs, carbon footprint reduction efforts, and sustainable supplier evaluations.
• Assist in tracking sustainability performance metrics and preparing reports for leadership reviews.
• Utilize Lean Manufacturing and Six Sigma tools to drive process improvements and operational efficiencies.
• Analyze production and quality data to identify trends, non-conformances, and opportunities for improvement.
• Develop and execute validation activities, including IQ/OQ/PQ, as required for process changes.
• Partner with Supplier Quality and Procurement teams to evaluate environmentally preferred suppliers and materials.
• Review supplier quality documentation and support supplier qualification efforts.
• Create and maintain quality documentation including protocols, reports, procedures, work instructions, and validation records.
• Support technical documentation updates associated with sustainability projects and product/process improvements.
• Present project updates, quality metrics, and sustainability results to management and stakeholders.

Essential Skills

• Bachelor's Degree in Engineering, Quality Engineering, Industrial Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• Minimum of 2 years of Quality Engineering experience in Medical Device Manufacturing.
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, Root Cause Analysis methodologies, CAPA processes, and Risk Management principles.
• Experience supporting manufacturing process improvements.
• Strong analytical, documentation, and problem-solving skills.
• Proficiency with Microsoft Office Suite and quality data analysis tools.

Additional Skills & Qualifications

• Experience supporting sustainability, environmental, ESG, or green manufacturing initiatives.
• Knowledge of Lean Manufacturing, Six Sigma, or Continuous Improvement methodologies.
• ASQ Certified Quality Engineer (CQE) certification preferred.
• Familiarity with Life Cycle Assessment (LCA) concepts and sustainable product development.
• Experience with process validation (IQ/OQ/PQ).
• Green Belt or equivalent continuous improvement certification.

Work Environment

This is a fully remote position.

Job Type & Location

This is a Contract position based out of Largo, FL.

Pay and Benefits

The pay range for this position is $40.00 - $50.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 2, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.