Sr. Supplier Quality Engineer (12 month contract // Mounds View, MN):

Candidate will be required to be on site in Mounds View, MN but will have some hybrid flexibility 1-2 days per week depending on project demands

Can you please confirm your top 3 skills sets required?

1. Supplier Management and Supplier Controls knowledge to develop supplier controls and qualification plans and reports to assure components, materials and suppliers meet specified requirements and performance, reliability goals.
2. High Technical Rigor, review and approve changes to client’s specifications and review and approve supplier changes.
3. Develop technical solutions to complex problems using the corrective/preventative action.

Primary Responsibilities:

• Support the evaluation and selection of global best-in-class components suppliers/CM/OEM through the application of appropriate tools and measurements
• Partner with multiple functions, including Supplier Quality, Design Engineering, Manufacturing, Quality, Reliability and Regulatory to evaluate, select and approve component or materials for active projects.
• Partner with suppliers to ensure components / materials / sub-assemblies are qualified and validated to the appropriate requirements prior to commercialization.

Target Years of Experience: 4 years of experience in quality or engineering

Description:

This role of pre-market Supplier Quality Engineering will directly be the key partner for selected development projects up to product launch. Will own different projects from early development phase up to post market transition. It would be essential to have knowledge of supplier controls, process validation, supplier and internal auditing, failure investigation techniques, statistical quality control, protocol/report preparation, and non-conforming product controls.

Duties:

• Review and approve changes to client’s specifications for purchased materials
• Develop and maintain controls and qualification plans and reports
• Review and approve supplier change requests and partner with Sourcing Engineering to develop and implement appropriate strategies to qualify and support the change approval process
• Develop technical solutions to complex problems using the corrective/preventative action process
• Analyze and identify trends from quality data
• Lead or participate in supplier audit/assessment of current or future suppliers
• Ensures that suppliers deliver quality parts, materials, and services
• 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
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation

Required Knowledge and Experience:

• 4 years of experience in quality or engineering
• Experience with Supplier controls and qualifications
• Process validation, including Protocol/Report preparation
• Supplier and Internal auditing
• Statistical Quality/Process Control
• Failure Investigation techniques and Non-conforming Product controls

Nice to Have:

4 years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise