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.