Sr Supplier Quality Engineer

Job Description

Job Description

Title: Sr Supplier Qual Engineer

Location: Grand Rapids, MI 49504

Job Description:

• This supplier quality role will have reasonability for management of suppliers within the Grand Rapids, MI SQE Team.

Must Have:

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

Top 3 technical skills:

• 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

Product line will this person support: Cardiac Surgery - Cannula, Heart Positioners.

Responsibilities:

· 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. Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.

· 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. Including implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.

· 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 Medtronic 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-functional with internal stakeholders and interacts with multiple levels of personnel internally and externally to ensure timely completion and approvable output of Supplier CAPA records.

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

Company Description

We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.