Supplier Quality Engineer III

Alphatec Spine•Carlsbad, CA

7d•$110,000 - $125,000•Onsite

About The Position

The Supplier Quality Engineer (SQE) III is responsible for leading supplier quality activities and driving the quality performance of external product and service suppliers used in spinal orthopedic implants, instruments, software, and capital equipment. This role serves as a technical leader within Supplier Quality, providing expertise in supplier auditing, supplier development, supplier risk management, corrective action management, supplier process qualification, and supplier performance improvement. The SQE III partners closely with Supply Chain, Purchasing, Operations, R&D, Manufacturing Engineering, Regulatory Affairs, and Quality teams to ensure supplier performance supports business objectives, regulatory compliance, product quality, and supply continuity. This position operates with minimal management oversight and serves as the primary quality leader during supplier engagements and quality escalations.

Requirements

Medical device industry experience required.
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.
Ability to travel approximately 10-30% as required.
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.
Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.

Nice To Haves

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.

Responsibilities

Lead supplier quality activities, including supplier performance management, issue resolution, supplier development, and continuous improvement initiatives.
Develop and maintain strategic relationships with assigned suppliers while serving as the primary quality contact.
Lead supplier qualification, requalification, classification, and supplier development activities.
Evaluate supplier quality system effectiveness and manufacturing process controls using risk-based decision-making principles.
Drive supplier performance improvement initiatives supporting quality, delivery, compliance, and operational excellence objectives.
Support Approved Supplier List strategy and supplier risk management activities.
Serve as Lead Auditor and regularly conduct supplier quality system and process audits.
Develop supplier audit plans, audit reports, audit finding responses, and effectiveness reviews.
Lead supplier audit finding closure, corrective action follow-up, and verification of effectiveness.
Represent Supplier Quality during internal audits, external audits, and regulatory inspections.
Lead complex Supplier Corrective Action Requests (SCARs) from initiation through effectiveness verification.
Lead supplier-related NCR investigations, containment activities, disposition strategies, and corrective action implementation.
Facilitate structured root cause investigations using methodologies such as 8D, DMAIC, Fishbone, Fault Tree Analysis, and 5 Why analysis.
Lead difficult supplier discussions and quality escalations while maintaining productive supplier relationships.
Independently manage complex supplier quality issues with minimal management support.
Lead Supplier Change Request reviews, ensuring appropriate risk assessment and cross-functional evaluation.
Lead supplier-specific process FMEAs and supplier process risk assessments.
Evaluate the impact of supplier changes on product quality, validation status, regulatory compliance, and business continuity.
Develop risk mitigation plans for critical suppliers, processes, and commodities.
Partner regularly with Strategic Supply Chain and Purchasing teams to support sourcing decisions and supplier strategies.
Lead supplier business reviews and supplier quality performance reviews.
Develop supplier improvement roadmaps focused on capability, capacity, compliance, responsiveness, and quality performance.
Support new supplier onboarding, second-source development, and supplier transfer activities.
Lead supplier qualification activities, including process development, capability studies, process validation support, Gage R&R studies, correlation studies, and First Article activities.
Provide statistical leadership supporting supplier process controls and manufacturing improvements.
Support complaint investigations, design transfer activities, and post-market quality investigations involving suppliers.
Provide supplier quality input to New Product Development, Design Transfer, Manufacturing Readiness, and sustaining product activities.
Lead development, negotiation, implementation, and revision of supplier Quality Agreements.
Lead continuous improvement initiatives within Supplier Quality and assigned supplier areas.
Mentor Supplier Quality Engineers and Quality Engineers on auditing, supplier risk management, supplier investigations, and supplier development practices.
Share supplier lessons learned, quality trends, and best practices across Quality Engineering, Operations, Purchasing, and Supply Chain teams.