Manufacturing Quality Engineering Co-op

Role Summary

The Manufacturing Quality Engineering Co-op supports sustaining and improving quality processes across the manufacturing workflow to ensure a quality product is produced and quality procedures are upheld. This role is based in Danvers, MA and is part of the Abiomed Quality Team.

Responsibilities

• 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.

Qualifications

• Required: Undergraduate or graduate student pursuing a degree in engineering.
• Preferred: Focus in medical devices.
• Required: Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
• Required: Execute tasks in a timely manner without direct supervision. Able to prioritize tasks.
• Required: Proficiency in Microsoft Office Suite.
• Required: Authorization to work in the United States without sponsorship (no visa sponsorship now or in the future).