ATEC Spine · 21 hours ago
Supplier Quality Engineer II
Carlsbad, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $120K/yr
2+ years expATEC Spine is a company focused on spinal orthopedic implants, instruments, software, and capital equipment. They are seeking a Supplier Quality Engineer II responsible for executing supplier quality activities and supporting the quality performance of external product and service suppliers, while working cross-functionally to support new product development and sustaining activities.
Health CareMedical DeviceProduct Design
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
Qualification
Required
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
Preferred
Experience supporting suppliers of powered surgical instruments or medical electronics
Company
ATEC Spine
ATEC Spine is a medical device company dedicated to revolutionizing the approach to spine surgery through innovation.
501-1000 employees
H1B Sponsorship
ATEC Spine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (5)
2023 (5)
2022 (2)
2021 (3)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.02BKey Investors
Squadron Medical Finance Solutions
2025-03-03Post Ipo Debt· $350M
2023-10-24Post Ipo Equity· $150M
2023-04-19Post Ipo Equity· $60M
Leadership Team
Pat Miles
Chairman & CEO
Craig Hunsaker
Executive Vice President, People & Culture
Recent News
MarketScreener
2025-11-03
2025-11-01
2025-10-31
Company data provided by crunchbase