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.
Essential Duties and Responsibilities- Supplier Quality Management
- 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.
- Supplier Corrective Actions and Quality Escalations
- 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.
- Supplier Change and Risk Management
- 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.
- Supplier Development and Business Partnership
- 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.
- Product and Process Support
- 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.
- Quality Agreements and Continuous Improvement
- 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.
RequirementsThe requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 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.
Education and Experience- 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.
Certificates, Licenses, Registrations - 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.
Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Working conditions are normal for an office and manufacturing environment. Work may involve lifting of materials and product up to 30 pounds. Working in this environment requires the use of safety equipment to include but not limited to; eye safety glasses, hearing protectors, and work boots.
Salary RangeAlphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $110,000 to $125,000 Full-Time Annual Salary
