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Sr. Manager, Quality Assurance

4 months ago

Billerica, United States EPM Scientific Full time

Title: Quality Assurance Manager (Medical Device)

Location: Billerica, MA

A pharma/med device company is seeking a Quality Manager to spearhead Quality activities related to their combination products. The Quality Manager will be responsible for all aspects of QA for medical devices manufactured on site or through third party contractors.

Responsibilities:

  • Review and approved Device History Records
  • Work on technical investigations relating to product complaints
  • Oversight of vendor/supplier management program change notifications, audit schedule, status tracking, etc.
  • Ensure site inspection readiness for both internal and external audits

Qualifications:

  • Bachelors degree with approx. 8-10 years of Quality experience in medical device, combination product experience preferred
  • Direct experience with medical device complaints investigations and inspection readiness
  • Experience working directly with FDA/notified bodies
  • Must be authorized to work in the united states without sponsorship

If you are curious to hear more, please do not hesitate to apply