Quality Engineer

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.

• 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.

• 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.

• 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.

This is a fully remote position.

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

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…