Supplier Quality Engineer III
$150,000–$200,000 year
On-siteCarlsbad, California, United States
Job Summary
Lead supplier quality activities, including performance management, issue resolution, and continuous improvement initiatives for external suppliers in spinal orthopedic implants and capital equipment. Serve as the primary quality contact and Lead Auditor, conducting regular quality system audits, developing audit plans, and managing finding closure and corrective action verification. Independently manage complex Supplier Corrective Action Requests (SCARs), root cause investigations using methodologies like 8D and DMAIC, and quality escalations with minimal management oversight. Drive supplier development, risk management, and process qualification while partnering with Supply Chain, R&D, and Regulatory Affairs to ensure compliance with FDA 21 CFR Part 820 and ISO 13485. Lead supplier business reviews, develop improvement roadmaps, and mentor junior engineers on auditing and risk management practices. Requires 4-15 years of experience in medical device supplier quality, Lead Auditor certification, and the ability to travel 10-30%.
Required Qualifications
- Medical device industry experience
- Strong understanding of FDA 21 CFR Part 820, ISO 13485, MDSAP, ISO 14971, and purchasing controls
- Lead Auditor certification or demonstrated ability to independently lead supplier audits
- Experience leading supplier audits, supplier assessments, SCARs, supplier NCRs, and supplier quality investigations
- Strong knowledge of SPC, DOE, Gage R&R, process capability, root cause analysis, manufacturing process validation, mechanical inspection, and GD&T
- Ability to read, analyze, and interpret blueprints using ASME Y14.5 GD&T principles
- Ability to communicate effectively with suppliers regarding NCRs, SCARs, containment, root cause, corrective action, objective evidence, and effectiveness checks
- Ability to develop and maintain strong working relationships with internal and external customers and suppliers
- Ability to solve complex problems to root cause and prevent recurrence
- Strong technical writing skills for reports, procedures, audit records, supplier communications, and quality documentation
- Detail oriented with sound decision-making skills and judgment
- Ability to execute plans and strategies to completion with minimal management oversight
- Bachelor's degree from a four-year college or university in Engineering or a related technical discipline, or equivalent experience
- Typical experience range is 4-15 years in quality engineering, supplier quality, manufacturing engineering, or a regulated manufacturing environment
- Ability to travel approximately 10-30% as required
- Candidates must be authorized to work in the United States without the need for current or future employer sponsorship
Desired Qualifications
- ASQ CQE (Certified Quality Engineer), ASQ CQA (Certified Quality Auditor), and Lead auditor certification preferred
- Strong working knowledge of DMAIC/Six Sigma problem solving process preferred
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