ATEC Spine · 1 day ago
Quality Engineer - Sustaining
Carlsbad, CA
Contract
Onsite
Mid Level
$80K/yr - $90K/yr
3+ years expATEC Spine is focused on providing high quality implantable and non-implantable spine surgery medical devices. The Quality Engineer will ensure compliance with regulatory requirements and support the manufacture of these devices, working closely with various teams to maintain product quality and lead continuous improvement projects.
Health CareMedical DeviceProduct Design
Responsibilities
Support Material Review Board (MRB)
Develop and revise inspection methods, gages and associated drawings and procedures
Support Engineering Change Order Review
Perform Design For Manufacturing activities (DFM)
Technical interface with contract manufacturing
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
Lead continuous improvement projects
Participate in FDA, ISO, and other regulatory audits
Other duties as assigned
Qualification
Required
Knowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485), and other applicable standards
Experience supporting on-market / commercialized product
Knowledge of mechanical inspection methods and equipment
Knowledge of SPC, DOE, probability, and statistics
Ability to read, analyze, and interpret blueprints and GD&T
Ability to solve complex problems to root cause and prevent re-occurrence (CAPA)
Ability to write reports and procedures
Ability to effectively interact with all levels of the organization
Ability to develop and maintain strong working relationships with internal and external customers and suppliers
Knowledge of Solid Works or other CAD software
Detail Oriented
Good decision-making skills and judgment
The ability to execute plans/strategies to completion
Working knowledge of biocompatibility requirements
Must be able to travel up to 10% of the time
Minimum Bachelor's degree (BS) from a four-Year College or university in Mechanical, Industrial and Systems, Biomedical, or Manufacturing Engineering
3+ years related experience and/ or training; or equivalent combination of education and experience
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