Principal Supplier Quality Engineer (Medtech)

TL;DR

Principal Supplier Quality Engineer (Medtech): Managing strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) with an accent on supplier performance, compliance, and quality improvements. Focus on ensuring supplied products conform to medical device requirements, preventing defects, and maintaining regulatory compliance.

Location: Remote (Must be based in the United States)

Salary: $123,200 - $184,800

Company

Global healthcare technology leader focused on alleviating pain, restoring health, and extending life through medical device innovation.

What you will do

• Manage strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) to ensure quality delivery.
• Maintain controls and drive continuous improvements for finished medical device and component quality within supplier systems.
• Collaborate with internal R&D, Quality, and Regulatory teams to ensure product conformity and prevent defects.
• Develop and execute auditing schedules to ensure Good Manufacturing Practices (GMP) and quality standards are met.
• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the New Product Development (NPD) lifecycle.
• Define Receiving Inspection requirements and associated test method validations for internal test methods.

Requirements

• Bachelor’s Degree in Engineering, Science, or technical field with 7+ years of experience, or an Advanced degree with 5+ years, or a PhD with 3+ years in Engineering/Quality.
• Must be based in the United States.
• Valid U.S. work authorization required (Sponsorship available for Principal-level roles).
• Availability for 10% to 15% travel to support collaboration and project completion.

Nice to have

• Experience supporting external contract manufacturers for finished medical devices and managing supplier quality agreements.
• Advanced knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience leading complex supplier investigations, root cause analysis, and CAPA development.
• Certification as a lead auditor or equivalent training in performing supplier audits.
• Experience implementing PPAP packages, including PFMEA, MSA, and capability studies.
• Certification in Lean or Six Sigma (Green Belt or higher).

Culture & Benefits

• Competitive base salary with eligibility for the hirify.global Incentive Plan (MIP).
• Comprehensive Health, Dental, and Vision insurance, including HSA and Healthcare Flexible Spending Accounts.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and an Employee Stock Purchase Plan.
• Tuition assistance/reimbursement and access to the Simple Steps global well-being program.