Quality Assurance Manager for Medical Devices

7 days ago


Newton, Massachusetts, United States Lumicell Full time

About the Role

We are seeking a seasoned Quality Assurance Manager to oversee quality operations, regulatory compliance, and operational excellence of drug-device combination products at Lumicell.

Key Responsibilities

  • Lead quality operations, including design controls, document control, CAPAs, NCMRs, deviations, software quality, process validation, etc.
  • Act as a subject matter expert in design quality and risk management to support product improvements
  • Lead supplier quality management for drug and device supply chain, including evaluation/selection and supplier monitoring of suppliers
  • Conduct internal/supplier audits and support external audits
  • Contribute to post-market surveillance activities, including complaint management, trending complaint data, and evaluation for corrections/recalls
  • Create routine quality metrics to monitor performance and support management review and ensure regulatory compliance
  • Support continuous improvement of quality management system (QMS) for drug-device combination product in compliance with applicable FDA regulations and relevant ISO standards
  • Collaborate closely with Product Development, Manufacturing Engineering, Field Service Engineering, Clinical/Medical Affairs, and Marketing/Sales Operations to integrate quality considerations throughout product life cycle
  • Support regulatory submissions for product changes, annual reports, etc.

Requirements

  • Bachelor's degree in Engineering, Life Sciences, Chemistry, Chemical Engineering, or a related technical discipline; Master's degree preferred
  • 5-10+ years of experience in quality roles within the medical device and/or pharmaceutical industry
  • Comprehensive knowledge of FDA and international regulatory standards applicable to medical devices and pharmaceuticals
  • Proven track record in managing supplier quality across a complex supply chain
  • Previous experience with complaint management
  • Adept with electronic QMS maintenance and continuous improvement
  • Excellent problem-solving, organizational, and communication skills

Estimated Salary Range:$120,000 - $160,000 per year

Lumicell offers a competitive salary, benefits package, and opportunities for growth and development. If you are a motivated and experienced Quality Assurance professional looking for a challenging role, please submit your application.



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