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Develop and improve, with an emphasis on implementation, inspection methods, gages, process control techniques, standard operating procedures, inspection plans, test protocols and test reports to ensure safety, reliability and efficacy of new and current products and processes.

Essential Duties and Responsibilities

Lead management of Quality Engineering Deliverables for New Product Development

Lead Supplier Part Qualification for New Product Development

Technical interface with contract manufacturing

Lead Material Review Board (MRB)

Develop inspection methods, gages and associated drawings and procedures.

Support Design Control to ensure efficient effective and compliant new product launches

Support suppliers in performing IQ, OQ and PQ processes

Support Engineering Change Order Review.

Perform Design For Manufacturing (DFM)

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

Perform Failure Mode and Effects Analysis (FMEA) for design and processes.

Support validations regarding sterilization, cleaning and shipping.

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.

Extensive knowledge of Solid Works CAD software

Extensive knowledge of mechanical inspection methods and equipment

Extensive knowledge of SPC, DOE, probability and statistics

Ability to read, analyze, and interpret blueprints and GD&T

Ability to write reports and procedures

Ability to effectively interact with all levels of the organization

Working knowledge of lean principals and implementation

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

Ability to solve complex problems to root cause and prevent re-occurrence (CAPA)

Technical writing of procedures and reports

Detail Oriented

Good decision making skills and judgment

The ability to execute plans/strategies to completion

Extensive knowledge of cleanability/sterilization (steam, EtO and Gamma) including dose mapping and dose audits.

Extensive knowledge of biocompatibility requirements

Must be able to travel up to 25% of the time

Education and Experience

Minimum Bachelors degree (BS) from a four-Year College or university in Mechanical, Biomedical, Industrial, Systems, or Manufacturing Engineering.
Minimum of 5 years related experience.
Must have a minimum of 1 year in medical device environment.

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 candidates qualifications, education, skill set, years of experience, and internal equity. $110,000 to $122,000 Full-Time Annual Salary

Alphatec Spine

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