Quality Assurance Engineer - Medical Device
Quality Assurance Engineer - Medical Device
Direct message the job poster from Kaye/Bassman International
Experienced Biotech & Pharma & Medical Device Regulatory Affairs & Quality Recruiter | Kaye/Bassman International
My client seeks a highly motivated and detail-oriented Quality Assurance Engineer with 3–5 years of experience in the medical device industry. This role supports manufacturing, quality systems, and product development to ensure compliance with regulatory requirements and company standards.
Responsibilities:
* Support Material nonconformance investigation and disposition activity, participate in weekly MRB meetings, and follow-up on supplier issues.
* Assist with the maintenance of the 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;
* Must have 3 - 5 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.
* Must have prior experience with CAPAs.
* 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.
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance, Engineering, and Project Management
* Industries
Medical Equipment Manufacturing
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