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Quality Assurance Manager

3 months ago

Billerica, United States G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing) Full time

Our client located in Billerica, MA is looking for a Head of QA to join their team. This is a direct hire opportunity.

Responsibilities: Our client in the pharmaceutical industry is looking for a candidate to oversee and lead a new product line. Looking for a candidate who has expereince with with a medical device product in a pharmaceutical setting. Responsible for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer. Ensure all medical devices manufactured meet established specifications. Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR/98-282), EU Medical Device Regulation 2017/745. Conduct FDA audits. Ensure site readiness for regulatory agency inspections and/or Sun Corporate Audits. You will have no direct reports.

Experience: 10+ years working in Pharma or Medical Device. 10+ working as a QA Manager or QA Director. Bachelors Degree in Life Sciences/ Engineering. Experience with FDA audits. Experience with Combination Products and Device History Records (DHR). Pharma quality compliance experience is a must. Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc. Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred.

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