Billerica , MA 01803 US
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Title: Quality Engineer
Hiring Organization: Connexion Systems & Engineering
- Duration: Perm
- Pay rate: $70-110K
- Job Location: Billerica, MA
- Job# 14969
As Quality Engineer, he/she will uphold and improve the product quality of medical devices manufactured and meet regulatory requirements to stay in compliance.
- Executes day to day activities based on quality objectives (goals) complementary to corporate policies and goals of building high quality medical devices.
- Evaluates medical device failures (product complaints) and writes a summary report
- Determines root cause and implements Corrective and Preventative Actions (CAPA)
- Reads and Interpret Standards in biocompatibility, sterilization and mechanical product testing for developing and updating Standard Operating Procedures and Reviewing or Creating Protocols/Reports.
- Evaluates risk in product design and the manufacturing process of medical devices
- Audits the manufacturing process to confirm compliance to procedures used to manufacture medical devices for assembly, packaging, chemistry formulation of solutions, inspections and testing of the medical devices.
- Updates the quality system based on non-conformities found during internal and external audits
- Reviews Non-Conforming Material Reports for plan and disposition
- Analyzes and reports quality system data to the quality and manufacturing teams
- Evaluates supplier performance based on data collected at incoming inspection.
- degree (B.A.) from four-year college or university in mechanical engineering or biomedical engineering or related field; and a minimum of two year of experience in the medical device industry. Understands common medical device standards ISO13485, ISO10993 and ISO14971. Experience in using MS Word, Excel, Power Point and Outlook. Strong oral and written communication skills.
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