Sr. Quality Engineer - Medical Device
The Judge Group Inc.

Location: Marlborough, MA
Salary: Negotiable
Description: Our client is currently seeking a Sr. Quality Engineer - Medical Device/ON SITE position
***All candidates must live in the Metro-Boston & Rhode Island area***

Responsibilities:

• Support Material nonconformance investigation and disposition activity, participate in weekly MRB meetings, follow-up on supplier issues
• Assist with maintenance of calibration system
• Support Manufacturing Engineering in the creation, release and maintenance of DHR, routers, bills of material, and specifications for manufacturing
• Support Product development activities and design transfer into manufacturing
• Perform incoming inspection review and disposition of product components and subsystems
• Develop and/or revise routine procedures, work instructions, and test methods.
• Document all activities in compliance with applicable medical standards, regulations, and guidelines.
• Assist in investigations of quality issues arising from product complaints, CAPAs, and non-conforming reports.
• Support management of new and approved suppliers; participate in internal and supplier audits.
• Utilize problem solving tools to analyze and identify root causes and implement corrective actions.
• Make decisions and propose solutions based on calculated risks identified through data analysis.

Requirements

• 5 - 10 years of manufacturing quality experience within the medical device industry.
• 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, is preferred.
• Extensive working knowledge of 21 CFR 820 and ISO 13485.
• Strong working knowledge of Microsoft Word and Excel.
• Hands-on experience with any of the following manufacturing processes: Electro-mechanical assembly, ESD controls, Cabling, Clean room, Labeling, sterilization.
• Experience executing process validation and test method validation/Gage R&R activities.
• Strong documentation capability for protocol and report generation and review.
• Prior start-up experience is a plus.
• MUST have Class II (preferred) or Class III Medical Device experience THIS IS A MUST HAVE

Contact: psalvatore@judge.com

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

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