Manufacturing Quality Engineering Co-op

Company: Disability Solutions
Location: Danvers
Posted on: September 28, 2024

Job Description:

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.\r\rPatients First - Innovation - Winning Culture - Heart Recovery\r\rPOSITION SUMMARY\rThe 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.\rKEY RESPONSIBILITIES

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• 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.\r\r

Keywords: Disability Solutions, Boston , Manufacturing Quality Engineering Co-op, Engineering , Danvers, Massachusetts