16 Jobs in billerica, ma
G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing) is Hiring a Quality Assurance Manager Near Billerica, MA
Our client located in Billerica, MA is looking for a Manager 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 Leader
- 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.
Job Summary
Full Time
$136k-168k (estimate)
06/20/2024
07/14/2024
The job skills required for Quality Assurance Manager include ISO, Quality Management System, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Assurance Manager positions, which can be used as a reference in future career path planning. As a Quality Assurance Manager, it can be promoted into senior positions as a Quality Assurance Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Manager. You can explore the career advancement for a Quality Assurance Manager below and select your interested title to get hiring information.
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