What are the responsibilities and job description for the Senior Supplier Quality Engineer position at Redbock - an NES Fircroft company?
Sr. Supplier Quality Engineer (12 month contract // Rice Creek, MN):
Candidate will be required to be onsite, but will have some hybrid flexibility 1-2 days per week depending on project demands, with onsite days typically being Tuesday through Thursday
Top 3 Skills:
- Problem-Solving Skills
- Technical Writing Skills
- Knowledge of Regulatory Requirements (ISO 13485, 21 CFR 820, GMP, and GDP)
Primary 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
Target Years of Experience: 3-10 years
Duties:
- 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 with 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 Test Methods.
Required Knowledge and Experience:
- 4 years of experience in supplier quality
- 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:
- 6 years of supplier quality engineering experience in the medical device industry or related field with supplier quality management expertise
- PPAP experience is preferred
