Senior Quality Engineer - 246067 - Greater Minneapolis-St. Paul Area

Job summary

Primarily responsible for providing technical support to ensure customer requirements are understood and properly implemented.

Responsibilities

• 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.
• Other duties as assigned.

Qualifications

• 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)

Desired requirements

• Previous experience with Class II or Class III medical device contract manufacturing and extrusion experience is preferred.

Job description