Regional Lead Quality Engineer

CSL SEQIRUS

Waltham, MA, United States
Base: $143,000 - $169,000; bonus/equity: not speci...
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21 cfr part 4 compliant quality system
Design control process
Fda / mdr regulations
** CSL Seqirus is seeking a Regional Lead Quality Engineer to oversee a team focused on the quality assurance of combination products, ensuring compliance with FDA and EU regulations throughout the product lifecycle. The role requires a strong background in quality engineering within the medical device sector, with responsibilities including guiding design development, vendor management, and maintaining quality systems. **

Job Summary

  • The Regional Lead Quality Engineer CP/MD is responsible for leading a regional team that supports the design, development, manufacture, and regulatory approval of combination products.
  • This role assures product development and site level execution of the local CP/MD Quality System for combination products, with emphasis on new product development activities.
  • The role requires a Bachelor’s degree in a relevant discipline and a minimum of 5 years of experience in medical devices or combination products.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking a Regional Lead Quality Engineer to oversee a team focused on the quality assurance of combination products, ensuring compliance with FDA and EU regulations throughout the product lifecycle. The role requires a strong background in quality engineering within the medical device sector, with responsibilities including guiding design development, vendor management, and maintaining quality systems. **

Salary

Base: $143,000 - $169,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 21 CFR Part 4 compliant quality system
  • Design Control process
  • FDA / MDR regulations
  • ISO and other industry standards
  • Risk analysis
  • Statistical data analysis
  • Sampling plan development
  • Vendor management activities
  • Six Sigma problem solving

Nice-to-have

  • Drug-delivery combination products experience
  • Connected health solutions experience
  • Mobile/web apps experience
  • Embedded software experience

Key Requirements

  • Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline
  • Minimum 5 years of experience as a quality, packaging, engineer or manufacturing professional in medical devices or combination products field
  • Minimum 2 years practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation / verification (V&V), usability / human factor studies, DHFs, design transfer
  • Working knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, relevant FDA guidance, relevant standards

Work Rights

Not specified

Tailored Resume

Cover Letter