Description: Job Description Contribute to the development of new products and sustaining of legacy products with a focus on Manufacturing Quality and Compliance activities.
Responsible for the overall manufacturing quality of disposable and capital equipment production lines
Supervise incoming inspection processes
Drive material nonconformance investigation and disposition activity, facilitate MRB meetings
Participate in supplier selection and qualification processes. Follow-up on supplier issues, including notifications, corrective actions and supplier audits. Maintain supplier files.
Review and improve calibration and preventive maintenance procedures
Responsible for the environmental monitoring of a controlled environment room to meet ISO 14644 and 16498 standards; manage non-viable and viable airborne particulates, and viable work surfaces sampling testing program to monitor product quality
Provide ongoing quality engineering support throughout the product lifecycle, including CAPA and complaint investigations, risk management, design and manufacturing changes.
Author validation, verification and inspection documentation, including process validation plans, protocols, and reports associated with Equipment Qualification (IQ/OQE/URS), Process Validation (OQP/PQ/MPQ), and Test Method Validations (TMV or MSA). Select appropriate tests and sampling sizes based on critical and statistical calculations. Support manufacturing and engineering in performing validation activities
Plan and develop statistical studies including DOEs, T-tests, Distribution ID, process capabilities, reliability tests, Gage R&R, and other statistical tools.
Conduct periodic trend analysis; maintain and present quality metrics in management review meetings.
5-10 years of manufacturing experience with Class II/III single-use and reusable medical devices manufactured in a high-volume,
Class 7 clean room environment
Hands-on experience with the following manufacturing processes: plastic injection molding, clean room commissioning and environmental monitoring.
Strong working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab.
Extensive working knowledge of 21 CFR 820 and
Strong working knowledge of Microsoft Word and Excel
Experience with lasers and optical technologies desired, but not necessary
Prior start-up experience is a plus
Education Required: Bachelor's Degree in electrical engineering or similar engineering field Personal
This job and many more are available through The Judge Group. Find us on the web at www.judge.com