Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
Patients First | Innovation | Winning Culture | Heart Recovery
The Manufacturing Quality Engineering Co-op will assist in sustaining and improving the quality processes across the manufacturing workflow to ensure quality product is produced and quality procedures are upheld.
· Participate in the investigation of failures and formulation/implementation of action plans for non-conformances, internal corrective actions, and audit findings.
· Work in cross-functional teams to identify and address non-conformances throughout assembly to final shipment of product.
· Work with engineering teams to ensure quality procedures are followed in all manufacturing and distributing areas.
· Use Lean and Six Sigma tools to analyze non-conformance data and identify opportunities for improvement across Material Review Boards (MRB) and other processes.
· Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
· Assist in the development and maintenance of quality documentation, including investigation reports, correction efforts, CAPAs, and process FMEAs.
· Assist in reviewing process validations and equipment qualifications, including plans, protocols, and reports.
· Utilize software tools to capture non-conformance data in order to analyze and identify trends for corrective actions or escalations.
· Undergraduate or grad student pursuing a degree in engineering. Focus in medical devices is preferred
· Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
· Execute tasks in a timely manner without direct supervision. Able to prioritize tasks.
· Proficiency in Microsoft Office Suite.
· Applicants must be authorized to work for any employer in the US. We will not be able to provide any sponsorship now or in the future.
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. Abiomed maintains a drug-free workplace.