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Quality Assurance Manager

Cambridge, MA, United States

Quality Manager

Cambridge, MA

$135,000 - £145,000

Medical Device

The ideal candidate is a critical thinker who will proactively improve the quality systems of our implantable medical device client through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.

Responsibilities

Develop standardized production, quality, and customer-service standards

Identify potential risks before they become a problem, focusing on root cause analysis and preventive action

Maintain and improve the quality management system (eQMS)

Perform internal and external quality audits and compile detailed reports of findings

Build a strong team through coaching, mentoring, specific training and performance evaluations

ISO 13485 Audits

Root cause analysis

CAPAs, NCRs, Deviations

Qualifications

Bachelor's degree or equivalent experience in Engineering

ISO 13485 Auditor

ISO 9001 Auditor

5+ years' relevant work experience (Medical Device Environment)

Highly organized with excellent attention to detail

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