Quality Engineer

Actalent; Largo (FL); Remote; USD 55,000 - 69,000; Full time

Job summary

Actalent seeks a Quality Engineer with at least 2 years of medical device manufacturing experience to support sustainability initiatives while ensuring FDA compliance. You will partner with Quality, Manufacturing, Engineering, Supply Chain, and Sustainability teams to drive environmentally responsible improvements.

Responsibilities include maintaining 21 CFR 820 compliance, risk assessments, CAPA investigations, supplier and internal audits, data analysis, and validation activities.

Qualifications

• Minimum of 2 years of Quality Engineering experience in Medical Device Manufacturing.
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and CAPA.
• Experience in risk management and quality process improvements.
• Familiarity with Lean Manufacturing and Six Sigma concepts.
• Strong analytical, documentation, and problem-solving skills.
• Proficiency with quality data analysis tools.

Responsibilities

• Maintain compliance with FDA QSRs and internal quality standards.
• Evaluate sustainability-related process changes via change control.
• Conduct risk assessments (FMEA, FTA, HA) for sustainability.
• Support CAPA investigations and corrective actions.
• Participate in internal/external audits and supplier assessments.
• Identify opportunities for waste reduction and energy efficiency.
• Analyze processes to balance environmental impact with quality.
• Support material substitutions, packaging optimization, and recycling.
• Track sustainability metrics and prepare leadership reports.
• Utilize Lean/Six Sigma to drive improvements.

Skills

Quality engineering

GxP knowledge

Risk management

CAPA

Lean Six Sigma

Data analysis

Education

Bachelor's degree in engineering

Related technical discipline

Tools

MS Office

Minitab

Job description

Job Title: Quality EngineerJob 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 job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available 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 9, 2026.

Equal Opportunity Statement

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Accommodation Policy

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

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

Massachusetts Lie Detector

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 law shall be subject to criminal penalties and civil liability.

Artificial Intelligence (AI) Statement

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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.