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.

Key Responsibilities

• 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.

Required Skills and Experience

• 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.

Additional Details

• 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.