Sr. Quality Engineer
3 days ago
Industry: Medical Device
Title: Sr. Quality Engineer - Medical Device
Location: Marlborough, MA (Fully On-Site)
Duration: 6+ months contract
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.
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