Researcher at PDC

Medtronic
Posted

Post Expires

Type

Mid-level industry position

A Day in the Life

 

Responsibilities may include the following and other duties may be assigned.

  • 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.
  • Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
  • Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD 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 Component Engineers 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 Medtronic Test Methods.
Must Have: Minimum Requirements
Bachelor’s degree in Engineering, Science or Technical field with 4+ years of work experience in engineering and/or quality OR a Master’s degree in Engineering, Science or Technical field and 2+ years of work experience in engineering and/or quality.
 
Nice to Have
- Experience working in the medical device, biotechnology, automotive, aerospace or pharmaceutical industry
- Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV)
- Prior experience with electrical, chemical, plastics, mechanical, and/or electro-mechanical commodities
- 5+ years of directly relevant experience in a Supplier Quality Engineering role
- Advanced degree (MS and/or MBA), Master’s degree in Engineering or Scientific field with an emphasis in Engineering, Materials, Quality Assurance, or Quality Systems
- ISO 13485 Lead Auditor Certification
 - Experience with polymers, plastics and injection molding is highly desirable - Knowledge with PPAP/high volume process and part validation techniques
 - Knowledge of the Medical Device regulations (21 CFR 820 and ISO 13485) - ASQ certified quality engineer (CQE) and/or black belt certification
- Ability to work with minor guidance and under pressure - Ability to drive and deliver innovative, effective and timely solutions as well as mentor others in best practices and industry standards where applicable
- Low Cost Country/Asia/Europe experience combined with high tech/med-high volume processes
- Effective verbal and written communication skills in order to effectively communicate with internal customers and suppliers, and to develop and present communication plans and strategies. Must be a team player.

More Information

Posted

Post Expires

Type

Mid-level industry position

Northridge%2C%20United%20States

Northridge , United States