Lead Quality Systems Auditor

Fresenius Group
Waltham, MA
Category Healthcare
Job Description
Fresenius Medical Care is seeking a Lead Quality Systems Auditor to lead quality systems audits, schedules, and plans, and ensure compliance with applicable regulations and standards. The ideal candidate will have a strong background in quality management, regulatory compliance, and auditing, with experience in the pharmaceutical or medical device sector.

Requirements

  • Bachelor’s degree or equivalent combination of education and experience
  • 3rd party auditor training or equivalent education and experience
  • 10+ years of experience in quality management, regulatory compliance, quality engineering, and auditing
  • Knowledge of current regulations for pharmaceutical and medical devices
  • Knowledge of current standards and guidelines for pharmaceutical and medical devices
  • In-depth knowledge in the interpretation of FDA guidelines and Good Manufacturing Practices
  • Expertise in reviewing, revising, and writing Standard Operating Procedures
  • Strong analytical and conceptual skills
  • Ability to identify risks and compliance gaps and develop appropriate actions
  • Excellent communication and writing skills
  • Ability to work both independently and within project teams
  • High level of commitment, flexibility, and sense of responsibility
  • Willingness to travel internationally
  • Proficiency in using Microsoft Office applications

Benefits

  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid time off
  • Parental leave
  • Performance-based bonuses
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