Sr. Supplier Quality Engineer
Michigan, Kalamazoo-Battle Creek
Excellent Opportunity with Global Fortune 300 Medical Device Organization!
Sr. Supplier Quality Engineer
Located in Portage MI
Great Career Advancement Opportunities / Relocation Assistance Avail.
Summary of Position
Supplier Quality Engineers (SQEs) work with component suppliers, contract manufactures, and original equipment manufacturers, to ensure purchased components, sub-assemblies, and devices comply with all print specifications and applicable regulations. SQEs act as a technical liaison between suppliers, Engineering, Purchasing, and Manufacturing, to support projects and to resolve quality issues. This is a plant based role with 80% of the individual s time working with QE s, Production and the manufacturing environment.
RESPONSIBILITIES RELATED TO COMPLIANCE:
Ensure components, sub-assemblies, and devices meet all print specifications and applicable regulations.
Work with suppliers to quarantine all suspect and non-conforming material.
Issue supplier corrective action requests, and drive suppliers to identify and address true root cause.
Participate on supplier audits, as required.
Train/educate suppliers on GMP, regulatory requirements, and Corporate expectations.
RESPONSIBILITIES RELATED TO SUSTAINMENT:
Ensure an un-interrupted supply of conforming components to Operations.
Root cause analysis of part related manufacturing defects and warranty concerns
Manage supplier initiated changes; serve as the change owner in the corporate change management system.
Update prints and generate Engineering Change requests.
Support manufacturing transfer projects.
Disposition material quarantined in MRB.
RESPONSIBILITIES RELATED TO DEVELOPMENT:
Foster strong relationships with supplier-partners.
Analyze non-conformance data to prioritize projects and to solve systemic supplier issues.
Create and execute supplier development plans.
Drive continuous improvement actions with suppliers to reduce part related defects.
Evaluate and qualify of new suppliers, especially those with advanced technologies, to support product innovation.
Push lessons learned from the supply base back to R&D for incorporation into next generation designs.
QUALIFICATIONS / WORK EXPERIENCE
BS in engineering, or engineering related discipline required.
3+ years of relevant experience in Quality, Project Management, or Engineering.
Experience working onsite developing suppliers preferred.
Experience in production and process controls.
Expertise in problem solving and root cause analysis
Working knowledge of quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts.
Demonstrated collaboration, negotiation, and conflict resolution skills.
Ability to lead, champion change, and execute strategies to meet goals.
Critical thinking and strong analytical skills.
Familiarity with quality systems; ISO13485 & ISO9001 experience preferred.
Working knowledge of statistics and use of Minitab software: SPC, MSA, DOE, and Process Capability.
Process knowledge in assigned commodity (i.E. Plastics, metals, electronics, PCBAs, etc.)
Advanced working knowledge of MS Word, MS Excel, MS Visio, and PowerPoint 2007 .
ISO-13485 Lead Auditor certification preferred.
Experience conducting supplier audits and internal audits preferred.