Senior Manager Quality Systems
Job Summary
To support a growing global quality management initiative, the full-time Senior Manager Quality Systems will oversee compliance and continuous improvement of the Global Quality Management System, collaborating with cross-functional teams and ensuring regulatory alignment while working remotely.
Key responsibilities
- Support governance and continuous improvement of the global Quality Management System (QMS)
- Lead the global Management Review program, including planning, reporting, and action tracking
- Develop and maintain quality system KPIs and performance reporting to assess QMS effectiveness
Required qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, or a related field
- 8+ years of experience in quality management systems within a regulated med tech industry
- 7+ years of people leadership and team development experience
- Strong working knowledge of ISO 13485, FDA 21 CFR 820, and EU MDR requirements
- Experience with electronic Quality Management Systems (eQMS) such as MasterControl or Veeva
Complete Job Description
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