Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart Recovery
The Manufacturing Quality Engineer II 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:
- Provide Quality Engineering support in the development and manufacturing of new and existing disposable medical devices.
- Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
- Monitor & analyze production information to support risk management and lead corrective/preventative actions (CAPA)
- Support process validation of manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Represent Quality Assurance on Engineering Change Orders (ECO/ZEC) and Material Review Boards (MRB) for manufacturing and supply chain.
- Lead analysis of defective components found in Incoming Inspection, and work with suppliers to resolve issues (SCARs)
- Support the supplier evaluation process when selecting & qualifying new suppliers. Maintain the Approved Suppliers List (ASL,) supplier scorecards & audit suppliers as needed.
- University degree required in Engineering or Sciences discipline
- 2+ years of experience in QA/QE in the medical device field
- Experience with manufacturing of complex products in an ECA, ideally catheter-based or cardiac assist devices
- Good understanding of FDA QSRs, ISO13485 and ISO 14971
- Experience with formal problem-solving methodologies and deductive skills
- Experience with handling non-conforming material and assemblies, including root cause investigations
- Use of statistical data analysis; ideally Six Sigma methods & tools
- Experience with SAP or other ERP system is a plus
- Takes initiative and demonstrates leadership and team work
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.