Quality Engineer II

About the role

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.

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.
• Qualify 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

• 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.
• Able 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.
• Able 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.
• 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.
• Detail oriented.
• Good decision-making skills and judgment.
• Ability to develop plans and strategies and execute to completion.

Education & Experience

• 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; or equivalent combination of education and experience.