ATEC Spine · 6 days ago
Quality Engineer III
Carlsbad, CA
Full-time
Onsite
Mid, Senior Level
$110K/yr - $125K/yr
5+ years expATEC Spine is a company focused on developing and improving medical devices. The Quality Engineer III role involves leading quality engineering deliverables for new products, supporting new product development, and ensuring compliance with regulatory standards.
Health CareMedical DeviceProduct Design
Responsibilities
Support New Product Development (NPD)
Lead management of Quality Engineering Deliverables for new mechanical and tissue-based products, including Design Controls
Lead Supplier Part Qualification for new products including but not limited to PQs, GR&R, correlation studies and process development
Support qualification of legal manufacturers for distributed products
Develop Quality Inspection Records (QIR), Supplier Inspection Plans, Custom Gages and associated drawings and Standard Operating Procedures
Support Engineering Change Order Review
Support Design For Manufacturing (DFM) activities
Technical interface with contract manufacturing
Support Design Control to ensure efficient effective and compliant new product launches
Support suppliers in performing IQ, OQ, and PQ processes
Provide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification
Lead Risk Management efforts in accordance with ISO 14971
Perform Failure Mode and Effects Analysis (FMEA) for design and processes
Support validations regarding sterilization, cleaning, and shipping
Participate in MDSAP, FDA, ISO, and other regulatory audits
Support Supplier Corrective Action (SCAR) process
Lead Material Review Board (MRB) and participate in Supplier Review Board (SRB)
Lead Non-Conformances resolution, product reworks, and deviations approvals for medical devices in mature phase of product lifecycle
Support Design Transfer to Manufacturing (DTM) for sustaining products
Identify and implement process improvements
Act as liaison between supplier and company for quality related concerns or issues
Support customer complaint investigations on products manufactured by suppliers
Other duties as assigned
Qualification
Required
Extensive knowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485, MDSAP), and other applicable standards
Direct experience with implantable devices, instrumentation, and disposables, in a regulatory environment (GMPs, ISO13485)
Extensive knowledge of mechanical inspection methods and equipment
Extensive knowledge of SPC, DOE, probability, and statistics
Extensive knowledge in how to read, analyze, and interpret blueprints and GD&T
Strong ability to solve complex problems to root cause and prevent re-occurrence (CAPA)
Strong technical writing skills writing reports and procedures
Ability to effectively interact and influence with all levels of the organization
Ability to develop and maintain strong working relationships with internal and external customers and suppliers
Knowledge of manufacturing methods
Working knowledge of lean principals and implementation
Detail Oriented
Strong project management skills
Good decision-making skills and judgment
Strong initiative
Ability to execute plans/strategies to completion
Robust understanding of cleanability/sterilization (steam, EtO, and Gamma) including dose mapping and dose audits
Extensive knowledge of biocompatibility requirements
Must be able to travel up to 5% of the time
Minimum of 5 years related experience
Must have a minimum of 1 year in medical device environment
Preferred
Broad experience supporting on-market / commercialized product preferred
Experience with electromechanical and/or mechatronic devices and regulations preferred
Knowledge of Solid Works CAD software preferred
Prefer experience with electromechanical and/or mechatronic devices and regulations
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