Sr Supplier Qual Engineer - Exempt - Lancesoft : Job Details

This role will have responsibility for management of suppliers within the Grand Rapids, MI SQE Team. Responsibilities may include the following and other duties may be assigned:

• Ensures that suppliers deliver quality parts, materials, and services.
• Leads cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection.
• Lead and/or participate in corrective/preventive action teams in resolving supplier-related issues (e.g., nonconformances, CAPA activities, audit findings, complaint investigations, etc.).
• Coaches team members on supplier quality principles, quality system requirements, statistical analysis, and application of technical analysis to daily assignments.
• Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the product's lifecycle.
• Develops and delivers the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for existing products.
• Define Receiving Inspection requirements as required and associated test method validation for internal test methods.
• Evaluates and acts as a lead in processing and approving supplier change requests.
• Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• Supports internal and external audit and inspections, including preparation and resolution of audit and inspection findings.
• Collaborates cross-functionally with internal stakeholders and interacts with multiple levels of personnel internally and externally to ensure timely completion and approvable output of Supplier CAPA records.

Must Have

• Advanced Supplier Development
• CAPA
• DMAIC
• ISO 13485
• Medical Device
• Minitab

Top 3 Technical Skills Required

• Strong Background in Quality Systems related to Supplier Controls
• Proven Excellence in Problem Solving - DMAIC, CAPA, or similar
• Experience in SAP, Agile, and Track Wise (Nice to Have)

Education Required Bachelor's Degree and 4 years of relevant experience OR advanced degree with a minimum of 2 years relevant experience. Additional Information

• 40 hours per week, on-site.
• Timeline for scheduling interviews: As soon as possible.
• Product line supported: Cardiac Surgery - Cannula, Heart Positioners.