Senior Quality Engineer

Responsibilities

• Ensure all product, processes, and components are within specifications
• Serve as a member on collaborative cross-functional teams to support new product development, commercial production, material-related design changes, manufacturing and process changes, risk management activities, and other compliance projects
• Work in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016
• Lead the Device History Records (DHR) review and approval process
• Lead nonconformance reports (NCR) and CAPA investigations
• Lead the development and implementation of PFMEAs and control plans
• Lead process and equipment validation activities (IQ, OQ, PQ/PV, TMV)
• Lead manufacturing and quality system improvements
• Lead customer feedback process and investigations
• Author Engineering Change Orders (CO); support CO implementation tasks
• Ensure compliance with applicable standards and regulations through experience with engineering and technology
• Perform daily contact with members of Production, Engineering, Materials, and Quality departments
• Routine contact with design authority and customers; occasional contact with auditors

Qualifications and Skills

• 5+ years of experience related to the manufacturing of medical devices in a QMS environment while being in a Quality Control or Engineering role
• Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016
• Experience with Microsoft Office software (Word, Outlook, Excel)
• Experience participating in internal and external audits
• Strong project management, prioritization, and leadership skills
• Able to manage multiple priorities
• Performing statistical data analysis using Minitab or equivalent
• Presenting and leading meetings with an audience of peers and senior management level
• Using critical thinking and deductive reasoning to make risk based decisions
• Knowledge and comprehensive understanding of CAPAs, root cause analysis, and the 8D method
• Excellent oral communication and technical writing skills
• A high level of attention to detail and accuracy