Quality Engineer II

Alphatec Spine•Carlsbad, CA

4d•$90,000 - $110,000

About The Position

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.

Requirements

Good understanding of the FDA Quality System Regulations (21 CFR Part 820), ISO 13485, MDSAP, and ISO 19227.
Direct experience with implantable devices, instrumentation, and disposables in a regulated environment.
Knowledge of mechanical inspection methods and equipment.
Knowledge of SPC, DOE, probability, and statistics.
Ability to read, analyze, and interpret blueprints, including GD&T.
Ability to solve complex problems to root cause and prevent re-occurrence (CAPA).
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.
Ability to effectively interact with all levels of the organization.
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.
Excellent verbal and written communication, ability to resolve minor conflicts, collaborative teamwork.
Demonstrates tenacity in overcoming obstacles; proactive in taking initiative.
Detail oriented.
Good decision-making skills and judgment.
Ability to develop plans and strategies and execute to completion.

Nice To Haves

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.

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.