Sr Supplier Qual Engineer - Exempt
New Yesterday
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.
- Location:
- Grand Rapids
- Job Type:
- FullTime