Manufacturing quality engineering

Mechanical Quality Engineer supporting new product development.

Develop, improve, and implement quality methods and systems, working on cross functional teams in a regulated environment to ensure the safety, reliability and efficacy of products and processes.

Support New Product Development as primary QE for mechanical implants and instruments. Manage multiple concurrent major and minor projects.

Support the qualification of legal manufacturers (OEM) for distributed products.

Lead Material Review Board (MRB), own Non-Conformance (NC) development and resolution, lead reworks and deviations, participate in Supplier Review Board (SRB).

Develop inspection plans and custom gauging based upon required measurement and tolerances.

Support Change Order review for drawings, considering Design for Manufacturing (DFM) and Design for Inspection (DFI).

Act as liaison between supplier and company for quality related concerns or issues. Technical interface with contract manufacturers.

basic understanding of tests such as bioburden, BET, and dose audit testing.

Apply statistical techniques to analyze manufacturing processes and recommend appropriate process controls.

Support Risk Management efforts in accordance with ISO 14971; conduct preliminary risk assessments for projects. Support Failure Mode and Effects Analysis (FMEA) for designs and processes.

Support Field Retrieval Assessment (FRA) and Health Hazard Evaluation (HHE) as needed.

Support MDSAP, FDA, ISO, and other regulatory audits.

Apply external standards and guidance documents to project / product specific application.

Good understanding of the FDA Quality System Regulations (21 CFR Part 820), ISO 13485, MDSAP, and ISO 19227.

Knowledge of mechanical inspection methods and equipment.

Ability to process data, interpret data trends, and make basic recommendations based on findings.

Ability to troubleshoot and manage priorities across multiple projects based upon ATEC business priorities.

Strong technical writing skills, including ability to write protocols, reports, and procedures.

Shows desire and ability to take on small leadership roles within projects, effective communication and collaboration with team members.

Ability to develop and maintain strong working relationships with internal and external customers and suppliers.

Knowledge of SolidWorks or other CAD software preferred.

Manufacturing Engineering experience preferred, including knowledge of metal and plastic part production and processing. Process knowledge including milling, turning, EDM, 3D printing, and secondary processing.

Must be able to travel up to 5% of the time.

Minimum Bachelor's degree (BS) from a four-year college or university, preferably in Mechanical, Industrial, Biomedical, or Manufacturing Engineering.

2+ years related experience and/ or training; 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.

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).

At this time, ATEC Spine does not sponsor employment visas for this position. 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. $90,000 to $110,000 Full-Time Annual Salary

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