Sr. Quality Assurance Specialist

Title: Sr. Quality Assurance Specialist

Location: Billerica, MA

A pharmaceutical company is seeking a Sr. Quality Specialist to spearhead Quality activities related to their combination products. The Sr. QA Specialist 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. 5-8 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 have front-room audit experience
• Must be authorized to work in the united states without sponsorship

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