Job Description

A medical manufacturing client in New Hope, Minnesota is looking to hire a senior quality engineer to join their team. This Sr Quality Engineer is primarily responsible for providing technical support to ensure customer requirements are understood and properly implemented. This Sr Quality Engineer will also work cross-functionally contributing to development and manufacturing engineering qualification and validation activities. They will support Operations, Sales, and Quality by providing effective non-conformance processing, supplier control and outsourced services integrity, complaint handling, and related CAPA activities. They should also have experience providing effective technical support and Supervision to the QC/QA Inspection related functions so to directly ensure a constantly high-level of processing performance.

What We Are Looking For:

• 5-8 years of experience in ISO/FDA medical manufacturing environment
• Bachelor’s Degreen in Engineering, Sciences, Manufacturing, or equivalent related experience in manufacturing or quality control.
• Demonstrated skills related to root-cause analysis, SPS, equipment and process qualification, metrology, automation, and auditing are preferred.
• Strong communication abilities, confident disposition, team player, and a robust tool box of relevant software applications (business and quality)
• Previous experience with Class II or Class III medical device contract manufacturing complex catheters and extrusion experience is preferred.

Day To Day:

• Support and/or lead Qualification activities required by manufacturing process release.
• Support and/or contribute to process validation activities required for manufacturing process transfer.
• Champion and/or work jointly with manufacturing Engineers in effective processing of non-conformance events.
• Champion customer complaint and related CAPA processing performance.
• Support purchasing and receiving inspection activities to ensure acceptable raw material accuracy and timeliness.
• Support development activities for the transition of manufacturing processes and related controlled documentation (TVR Packages) from prototype control, to pre-production control to commercial production control.
• Promote and encourage strong QMS (Quality Management System), GMP (Good Manufacturing Practices), GDP (Good Documentations Practices) policies and principles throughout the organization.
• Champion and contribute to the QMS internal audit program effectiveness.
• Be available and support any supplier or external audit activities as requested by management.
• Lead and direct an effective QC/QA final inspection team to directly influence high product quality and output performance.
• Support key quality objectives on the production floor, including in-line inspections, lean manufacturing and improving throughput and scrap goals throughout the production and service provision processes

Salary of $85,000 - $110,000 + 8% bonus

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