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ABOUT US
Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: “Patients First.” With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,000 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
JOB DESCRIPTION
The Sr. Manufacturing Quality Engineer is responsible for cross-functional Quality Assurance, Quality Management/Compliance and activities associated with all Abiomed products and processes with a focus on manufacturing activities in the Danvers plant.
Primary Duties and Responsibilities:
- Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
- Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed
- Provide quality engineering support in the development and manufacturing of new and existing disposable medical devices.
- Represent Quality Assurance on Engineering Change Orders (ECO/ZEC) and Material Review Board (MRB).
- Gather and report on quality system metrics: manufacturing trends, complaint trends, MRR trends, etc.
- Support Quality Management System (process development, creating and editing new and existing SOPs); Support internal auditing requirements in manufacturing
- Make Quality decisions in areas of: Verification, ZECs, internal audits, risk assessments, disposition of non-conforming materials
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