Quality Engineer

The Quality Engineer will join our Quality Engineering team, focusing on New Product Introduction (NPI) activities. This role ensures the successful development and launch of high-quality implantable and non-implantable spinal surgery devices through compliance with regulatory, contractual, and quality system requirements. The Quality Engineer will 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 instruments and support mechanical implants. 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.
• Support Material Review Board (MRB) activities, nonconformance investigations and disposition decisions, manage rework and deviation activities, and participate in Supplier Review Board (SRB) reviews.
• 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 validation (IQ, OQ, and PQ) development and execution internally and at suppliers as needed.
• 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 as needed.
• Apply external standards and guidance documents to project / product specific application.
• Support Supplier Corrective Actions (SCARs) and Corrective and Preventive Actions (CAPAs).
• Perform other duties as assigned.