Quality Manager
Found in: Resume Library US A2 - 1 week ago
Job Duties:
Drive actions to improve performance to Client Facing Metrics, including timely delivery of solutions, manufacturing waste reduction, and timely addressing of quality issues and reduction of systematic contributors to defects.
Maintain the FDA QSR / ISO 13485 – compliant Quality Management System, including assignment of primary contacts and coordinating training support.
Manage production and process validation activities, and participate in technical reviews, FMEA, and feasibility discussions.
Act as direct contact (where appropriate) or manage contact (through Quality Engineers) for customer quality-related issues; coordinate course of action for alleviating and resolving concerns and providing timely responses.
Drive continuous improvement and scrap reduction initiatives.
Manage quality department, ensuring adequate staffing, training, and technical guidance to manage daily production activities.
Required Minimum Position Qualifications: Bachelor’s degree in Business Administration, Engineering (any), or related field of study; and 3 years of experience as a Senior Quality Engineer or Quality Engineer.
Position also requires demonstrated experience in the following:
ISO 13485 FDA regulations
Mini Tab Experience with Medical Device Manufacturing
Quality Management System
CAPA
To Apply: mail resume to Coeur HR, Ref Quality Manager, 209 Creekside Drive, Washington, NC 27889
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