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.