Senior Quality Engineer at The Judge Group Inc. in Marlborough, Massachusetts

Job Description:

Location: Marlborough, MA

Salary: Excellent

Description: Job Description Contribute to the development of new products and sustaining of legacy products with a focus on Manufacturing Quality and Compliance activities.


Job Duties

• 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.

Job Requirements

• 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


• ISO 13485


• 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

Contact: chindle@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com Apply Now