Supplier Quality Engineer II (Medical Devices)

TL;DR

Supplier Quality Engineer II (Medical Devices): Managing supplier quality for manufacturing sites with an accent on conformance to FDA and international regulations. Focus on performing supplier investigations, leading CAPA activities, and driving continuous improvement using Lean and Six Sigma tools.

Location: Onsite in Grand Rapids, Michigan, USA. Candidates must possess unrestricted U.S. work authorization.

Salary: $80,000 - $120,000 USD

Company

Global leader in healthcare technology dedicated to alleviating pain and restoring health through innovative medical technologies.

What you will do

• Manage suppliers and oversee performance and improvement activities for the Grand Rapids manufacturing site.
• Ensure supplied products conform to purchased materials and finished device requirements in compliance with FDA and international regulations.
• Lead investigations into supplier quality issues, including MRB, NCMR, and Supplier CAPAs.
• Coordinate New Supplier additions to the Approved Supplier List (ASL) and develop Product Acceptance Sampling Strategies.
• Define Receiving Inspection requirements and validate associated internal test methods.
• Utilize Lean, Six Sigma, and Kaizen tools to drive continuous quality improvement within the Quality System.

Requirements

• Bachelor’s Degree in Engineering, Science, or a technical field with 2+ years of work experience in Engineering and/or Quality.
• Alternatively, an Advanced Degree in Engineering, Science, or a technical field.
• Unrestricted U.S. work authorization at the time of hire and for the duration of employment.
• Ability to work onsite 5 days a week in Grand Rapids, MI.

Nice to have

• Proven supplier quality engineering experience within the medical device industry or other regulated industries.
• Strong knowledge of Quality System Regulation (21 CFR Part 820) and ISO 13485.
• ASQ Lead Auditor certification.
• Expertise in statistical quality control methods and Six Sigma principles.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and Healthcare FSA.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Employee Stock Purchase Plan and incentive plans.
• Tuition assistance/reimbursement and global well-being programs.