Quality Engineer II

Responsibilities

• Support New Product Development as primary QE for mechanical implants and instruments
• Manage Design Controls to ensure compliant new product launches
• Lead Material Review Board (MRB), Non-Conformance (NC) resolution, and Supplier Review Board (SRB) participation
• Develop inspection plans and custom gauging based on measurement and tolerances
• Support Change Order review for drawings considering DFM and DFI
• Act as technical liaison between suppliers and the company
• Support cleaning and sterilization validations (bioburden, BET, dose audit)
• Support validation (IQ, OQ, PQ) development and execution
• Apply statistical techniques to analyze manufacturing processes
• Support Risk Management (ISO 14971) and FMEA for designs and processes
• Own Supplier Corrective Actions (SCARs) and CAPAs
• Lead supplier part qualification including GR&R and first articles

Requirements

• Bachelor’s degree in Mechanical, Industrial, Biomedical, or Manufacturing Engineering
• 2+ years of related experience in a regulated environment
• Understanding of FDA 21 CFR Part 820, ISO 13485, MDSAP, and ISO 19227
• Direct experience with implantable devices, instrumentation, or disposables
• Knowledge of mechanical inspection methods, SPC, DOE, and statistics
• Ability to read and interpret blueprints and GD&T
• Strong technical writing skills for protocols, reports, and procedures
• Ability to travel up to 5% of the time

Preferred Qualifications

• Knowledge of SolidWorks or other CAD software
• Manufacturing Engineering experience with metal and plastic part production
• Process knowledge including milling, turning, EDM, 3D printing, and secondary processing