Quality Engineer - Sustaining

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

Essential Duties and 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.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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

Education and Experience

• 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).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $80,000 to $90,000 Full-Time Annual Salary