POSITION OVERVIEW:This positon will support manufacturing quality operations in a dynamic, fast-paced, medical device-manufacturing environment. This environment includes the manufacture, inspection, and test of devices for design verification, design validation, and commercial production.
RESPONSIBILITIES:- 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
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 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
EDUCATION: Bachelor's degree or equivalent experience in Manufacturing, Mechanical or related engineering / life sciences related discipline.
