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VitalPath · 12 hours ago

Sr Quality Engineer

St Paul, MN

Full-time

Onsite

Mid, Senior Level

$85K/yr - $110K/yr

5+ years exp

VitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world. The Sr Quality Engineer is responsible for providing technical support to ensure customer requirements are understood and implemented, working cross-functionally in development and manufacturing engineering qualification and validation activities.

Medical Device

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

Qualification

ISO/FDA complianceRoot-cause analysisEquipment qualificationProcess validationMetrologyAutomationAuditingSoftware applicationsClass II/III experienceExtrusion experienceCommunicationTeam player