Sr Supplier Qual Engineer Exempt

Join our dynamic team in Mounds View MN where you will have the opportunity to work on cutting-edge projects in the Cardiac Ablation System domain. We are seeking an experienced professional who is ready to contribute to our mission of delivering quality parts materials and services.

• Ensure suppliers deliver quality parts materials and services according to company standards.
• Qualify suppliers and administer a Certified Supplier Program to ensure cost-effectiveness.
• Monitor parts from acquisition through the manufacturing cycle and resolve supplier-related problems.
• Develop and prioritize an auditing schedule to ensure suppliers meet Good Manufacturing Practices (GMP) and quality standards.
• Evaluate suppliers internal functions to assess performance and provide feedback.
• Provide Pre-Market Quality Engineering support to New Product Development (NPD) teams.
• Collaborate with Component Engineers to develop Product Acceptance Sampling Strategy and Control Plans for new products.
• Define Receiving Inspection requirements and validate test methods for internal test methods.

• Demonstrated working knowledge of supplier controls process validation TMV failure investigation techniques and statistical quality control.
• Strong communication skills both written and oral with internal and external customers.
• Working knowledge of PPAP process and advanced knowledge of statistics and DOE execution.
• Familiarity with Quality System Regulation (QSR 21 CFR 820) Canadian Medical Device Regulation (CMDR) EU Medical Device Directive (EU MDD 93/42 EEC) and ISO 13485.
• Baccalaureate degree with a minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.

• Preferred onsite work at Mounds View site with potential for remote work if candidate has relevant experience.
• Target years of experience: 3-4 years.
• Interviewing to start within 2 weeks.
• Potential for immediate hiring based on candidate availability and demand.