Supplier Quality Engineer II

Alphatec Spine•Carlsbad, CA

1d•$100,000 - $120,000

About The Position

The Supplier Quality Engineer (SQE) II is responsible for executing supplier quality activities and supporting the quality performance of external product and service suppliers used in spinal orthopedic implants, instruments, software, and capital equipment. This role focuses on developing and maintaining supplier capability through audits, corrective actions, change management, and continuous improvement initiatives. The SQE II works cross-functionally with Supply Chain, R&D, Regulatory, Quality, and Operations to support new product development and sustaining activities. Essential Duties and Responsibilities Supplier Quality Management Manage supplier quality activities, including performance monitoring, issue resolution, and continuous improvement initiatives Build and maintain effective working relationships with assigned suppliers, serving as a quality point of contact and supporting on-site supplier visits, audits, and periodic business or quality reviews. Support supplier selection, approval, classification, and development through a combination of audits and product or process qualifications. Conduct on-site audits and supplier performance evaluations based on company procedures and ensures compliance with the supplier’s management system. Provides input into supplier audit schedules and ensure completion of audits per audit schedule. Utilize risk management methodologies to influence risk-based decisions tied to supplier qualification, supplier change requests, and nonconforming product. Support maintenance of the Approved Supplier List. Product Support Represent supplier quality engineering in technical teams, setting priorities for corrective action efforts and leading related failure investigations as required. Manage supplier change requests, ensuring cross-functional review, risk assessment, and compliance with internal change control and regulatory requirements. Support second sourcing initiatives by assisting with supplier qualification activities, risk assessments, and documentation to ensure alternate suppliers meet quality and regulatory requirements. Provide statistical support to suppliers allowing both to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification. Coordinate Manufacturer Qualification activities including but not limited to Part Qualifications, Gage R&R, correlation studies and process development. Perform customer complaint investigations on products manufactured by suppliers. Audits & Compliance Analyze supplier quality data and provide results for Management Review Supports SCAR process from beginning to end, implementing and follow-up of corrective and preventive actions. Participate in FDA, MDSAP, ISO and other regulatory audits. Traveling is approximately 10-30% as required. Other duties as assigned. Requirements The 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. Ability to perform supplier audits for multiple commodities (e.g. machining, motors, PCBAs, harnesses, coatings, injection molding, sterile packaging, software, electronics, etc.) Direct experience with medical instrumentation and disposables, in a regulatory environment (GMPs, ISO13485, MDSAP) required Experience supporting suppliers of powered surgical instruments or medical electronics (preferred) Must have knowledge of Quality Engineering discipline, including statistics. Thorough understanding of the FDA Quality System Regulations (21 CFR Part 820). Working knowledge of international quality system requirements, including the Medical Device Single Audit Program (MDSAP) and its application to supplier controls and purchasing processes. Thorough knowledge of mechanical inspection methods and equipment Exposure to electrical and functional test methodologies (e.g., continuity, insulation resistance, functional verification) Thorough knowledge of SPC, DOE, Gage R&R studies, probability and statistics Ability to read, analyze, and interpret blueprints utilizing ASME Y14.5 (GD&T) Ability to write reports and procedures Ability to communicate effectively with suppliers on NCRs and SCARs (e.g. developing scope of NCR, containment of product at supplier, RC/CA, evidence of RC and effectiveness) 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 re-occurrence Detail oriented Good decision-making skills and judgment The ability to execute plans/strategies to completion

Requirements

Ability to perform supplier audits for multiple commodities (e.g. machining, motors, PCBAs, harnesses, coatings, injection molding, sterile packaging, software, electronics, etc.)
Direct experience with medical instrumentation and disposables, in a regulatory environment (GMPs, ISO13485, MDSAP) required
Must have knowledge of Quality Engineering discipline, including statistics.
Thorough understanding of the FDA Quality System Regulations (21 CFR Part 820).
Working knowledge of international quality system requirements, including the Medical Device Single Audit Program (MDSAP) and its application to supplier controls and purchasing processes.
Thorough knowledge of mechanical inspection methods and equipment
Exposure to electrical and functional test methodologies (e.g., continuity, insulation resistance, functional verification)
Thorough knowledge of SPC, DOE, Gage R&R studies, probability and statistics
Ability to read, analyze, and interpret blueprints utilizing ASME Y14.5 (GD&T)
Ability to write reports and procedures
Ability to communicate effectively with suppliers on NCRs and SCARs (e.g. developing scope of NCR, containment of product at supplier, RC/CA, evidence of RC and effectiveness)
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 re-occurrence
Detail oriented
Good decision-making skills and judgment
The ability to execute plans/strategies to completion
Bachelor’s degree from four-year College or university in Engineering, or equivalent experience.
2-8 years of experience required.
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

Nice To Haves

Experience supporting suppliers of powered surgical instruments or medical electronics (preferred)

Responsibilities

Manage supplier quality activities, including performance monitoring, issue resolution, and continuous improvement initiatives
Build and maintain effective working relationships with assigned suppliers, serving as a quality point of contact and supporting on-site supplier visits, audits, and periodic business or quality reviews.
Support supplier selection, approval, classification, and development through a combination of audits and product or process qualifications.
Conduct on-site audits and supplier performance evaluations based on company procedures and ensures compliance with the supplier’s management system.
Provides input into supplier audit schedules and ensure completion of audits per audit schedule.
Utilize risk management methodologies to influence risk-based decisions tied to supplier qualification, supplier change requests, and nonconforming product.
Support maintenance of the Approved Supplier List.
Represent supplier quality engineering in technical teams, setting priorities for corrective action efforts and leading related failure investigations as required.
Manage supplier change requests, ensuring cross-functional review, risk assessment, and compliance with internal change control and regulatory requirements.
Support second sourcing initiatives by assisting with supplier qualification activities, risk assessments, and documentation to ensure alternate suppliers meet quality and regulatory requirements.
Provide statistical support to suppliers allowing both to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.
Coordinate Manufacturer Qualification activities including but not limited to Part Qualifications, Gage R&R, correlation studies and process development.
Perform customer complaint investigations on products manufactured by suppliers.
Analyze supplier quality data and provide results for Management Review
Supports SCAR process from beginning to end, implementing and follow-up of corrective and preventive actions.
Participate in FDA, MDSAP, ISO and other regulatory audits.
Traveling is approximately 10-30% as required.
Other duties as assigned.