Senior Supplier Quality Engineer (Medtech)

TL;DR

Senior Supplier Quality Engineer (Medtech): Managing and optimizing the quality of components and services from contract manufacturers for medical devices with an accent on reliability and quality compliance. Focus on auditing suppliers, implementing process improvements, and ensuring adherence to GMP and industry standards.

Location: Remote based in Colorado, USA. Required travel: 15% to Lafayette, CO and 20% to various Contract Manufacturers across North America.

Salary: $99,200 - $148,800 USD

Company

A global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Ensure suppliers deliver high-quality parts, materials, and services.
• Qualify suppliers according to company standards and administer Certified Supplier Programs.
• Develop and prioritize auditing schedules to ensure GMP and quality standards are met.
• Monitor parts throughout the manufacturing cycle and resolve supplier-related problems.
• Provide Pre-Market Quality Engineering support to New Product Development (NPD).
• Collaborate with Component Engineers on sampling strategies, Approved Supplier Lists, and Control Plans.

Requirements

• Baccalaureate degree with minimum 4 years of relevant experience, Master's with 2 years, or PhD.
• Must possess unrestricted U.S. work authorization (Sponsorship is not available for this level).
• Must be based in Colorado.

Nice to have

• Engineering-focused degree.
• Knowledge of FTQ, Lean, and 6 Sigma principles.
• Experience with Risk Management (DFMEA, PFMEA) and Validation (IQ, OQ, PQ, TMV).
• Knowledge of manufacturing assembly processes and inspection/testing methods.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Employee Stock Purchase Plan and Non-qualified Retirement Plan Supplement.
• Paid time off and holidays.
• Tuition assistance/reimbursement and the "Simple Steps" global well-being program.