Customer Quality Engineering Manager collaborating with medical device companies for quality assurance. Leading a team focused on customer quality activities and operational excellence.
Responsibilities
Provide leadership report-out of customer quality health with the top 10 strategic partners.
Provide oversight and approvals of Strategic Alliance Partner complaints and requests for Corrective Actions (SCARs).
Cross functional team member for product integrations with Strategic Alliance Partners.
Negotiation of Strategic Alliance Partner quality agreements and business contracts.
Track customer driven KPIs and ensure targets are being met.
Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance.
Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis.
Leads customer audit and inspection preparation, resolution of audit and inspection findings.
Prepares reports and/or necessary documentation and provides to applicable stakeholders.
Requirements
Bachelor’s degree required
Minimum of 5 years of relevant experience, OR Master’s degree with a minimum of 3 years of relevant experience
Project Management experience or training (Nice to Have)
Experience working with customers (Nice to Have)
Knowledge with Six Sigma or DRM (Nice to Have)
Strong analytical and problem-solving skills
Excellent communication skills
Previous management experience in a quality role (Nice to Have)
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