Senior Quality Engineer

Company: Catalyst Life Sciences
Location: Billerica
Posted on: May 14, 2022

Job Description:

Senior Quality Engineer A global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. committed to leading in high opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions, soft tissue repair and bone preserving joint technologies. Specific Responsibilities: providing support for new product development and manufacturing support for commercial products support the development and manufacture of medical device and drug/device combination products Designs, evaluates and implements quality assurance programs and systems for manufacturing and product development to ensure compliance with regulatory requirements Lead investigations, performs root cause analysis, prepares detailed investigation reports and implements corrective actions Develops, reviews protocols and reports to ensure quality attributes and analysis are being conducted Participates in the development of customer requirements and design inputs; works with team to ensure that customer requirements (user needs) can be validated and design requirements can be verified Facilitates the Risk Management Process in accordance with the latest version of ISO 14971; ensures integration of risk management outputs with design, process and regulatory requirements Experience, Knowledge and Skills Required: Requires a Bachelor---s Degree in engineering or related discipline minimum of 5 years related experience and demonstrated working knowledge of scientific principles; Master---s Degree preferred Working knowledge and demonstrated application of ISO 14971 Risk Management for Medical Devices

Keywords: Catalyst Life Sciences, Billerica , Senior Quality Engineer, Engineering , Billerica, Massachusetts