Senior Quality Engineer

• Working under the direction of the Quality Manager, ensure all product, processes, and components are within specifications.
• This position may also serve as a member on collaborative cross-functional teams, to support new product development efforts, commercial production, material-related design changes, and 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
• Use experience with engineering and technology to ensure compliance with applicable standards and regulations.
• Position requires daily contact with members of Production, Engineering, Materials, and Quality departments.
• Routine contact with design authority and customers; occasional contact with auditors

• 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 is required
• Experience with Microsoft Office software (Word, Outlook, Excel) required
• Experience participating in internal and external audits
• Strong project management, prioritization and leadership skills are required
• Must be 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
• Use 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
• High level of attention to detail and accuracy