Quality Engineer II

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.

Essential Duties and Responsibilities

• Support New Product Development as primary QE for mechanical implants and instruments. Manage multiple concurrent major and minor projects.
• Support Design Controls to ensure efficient, effective, and compliant new product launches.
• 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.
• Support cleaning and sterilization validations of implantable devices; basic understanding of tests such as bioburden, BET, and dose audit testing.
• Support validation (IQ, OQ, and PQ) development and execution internally and at suppliers.
• 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.
• Own Supplier Corrective Actions (SCARs) and Corrective and Preventive Actions (CAPAs).
• Lead supplier part qualification for new products including process qualifications (PQs), GR&R, first articles, and process development.

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.

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. $91,000 to $108,000 Full-Time Annual Salary