Quality Engineer, Sustaining

Alphatec Spine•Carlsbad, CA

6d•Onsite

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 shelf. Activities involve 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).
Proficient in Technical Writing (Protocols, Reports).
Knowledge of Solid Works or other CAD software.
Working knowledge of biocompatibility requirements.
The ability to execute plans/strategies to completion.
Project management and communication with internal and external customers.
Self-starter, works independently and maintains positive, enthusiastic attitude with a high-level of attention to detail/quality.
Ability to handle competing priorities and a broad variety of tasks simultaneously under high pressure and ambiguity.
Strong facilitation skills, confident communicator (both verbally and written) with all levels of organization and diverse audiences.
Ability to develop and maintain strong working relationships with internal and external customers and suppliers.
Ability to have good decision-making skills and judgment.
Must be able to travel up to 10% of the time to Alphatec Spine, Inc. facilities and suppliers.

Nice To Haves

Six Sigma Black Belt, ASQ CQE/OE (Certified Quality Engineer/Operational Excellence), preferred.

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.