Manufacturing Quality Engineering Co-op

Role Summary

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.

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.

Requirements

• Undergraduate or graduate 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 to provide any sponsorship now or in the future.