Supplier Quality Engineer

Summary

The company is seeking a Supplier Quality Engineer to ensure suppliers deliver quality parts, materials, and services for medical device products. The role manages supplier qualification and performance, resolves supplier-related issues, supports product acceptance and receiving inspection strategies, and drives quality compliance and continuous improvement across the product lifecycle.

Responsibilities

• 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
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation
• Partners with cross functional teams (R&D, sourcing, engineering, operations, quality), to deliver quality parts, materials, and services, prevent defects, and allow MiniMed to provide customers with the highest quality and reliable products
• Provides technical guidance and quality compliance throughout the product lifecycle (with focus on supplier changes) and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements
• Collaborates with cross functional teams to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products
• Define Receiving Inspection requirements as required and associated test method validation for all internal Healthcare Test Methods

Skills

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
• Bachelors degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
• Demonstrated experience on Medical Device Industry or Automotive part qualification requirements
• May have practical knowledge of project management
• Knowledge of ISO 13485 requirements
• FDA QMSR
• Geometric Tolerances
• Supplier Development, quality and process improvement
• Experience using Agile and Trackwise would be a plus

Qualifications

Must Haves

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
• Bachelors degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
• Demonstrated experience on Medical Device Industry or Automotive part qualification requirements
• May have practical knowledge of project management
• Knowledge of ISO 13485 requirements
• FDA QMSR
• Geometric Tolerances
• Supplier Development, quality and process improvement

Nice to Haves

• Experience using Agile and Trackwise would be a plus

Benefits

• Remote work arrangement