Quality Engineer - Sustaining

Alphatec Spine•Carlsbad, CA

1d•$80,000 - $90,000

About The Position

The Quality Engineer will join our Quality Engineering team , focusing on product sustaining. This role is responsible for supporting the manufacture of high quality implantable and non-implantable spine surgery medical devices by ensuring compliance with contractual and regulatory requirements. Working closely with our NPI QE team, contract manufacturers and quality control, you will ensure only good product goes on shelve. Activities involves assessing incoming inspection methods and sampling, process controls at the contract manufacturers, facilitating nonconforming material report investigation and closure, failure investigations, CAPA and SCAR ownership, and change control activities. This role liaisons with R&D, Quality NPI, Supplier Quality, Supply Chain and Regulatory and includes continuous improvement projects

Requirements

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.
0-2 years related experience and/ or training; or equivalent combination of education and experience.
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).

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.