Responsible for meeting customer requirements associated with the production of medical devices beginning with the receipt of an order, specifying raw material, processing, to the shipment and documentation of finished goods. Supports the development of internal systems and procedures to meet all customer specific, ISO 13485, and FDA 820/GMP requirements. Responsible for all monitoring and measurement devices.
Builds, manages and sustains a team of technical quality associates assigned to product development and in-process quality.
Ability to develop relevant training programs and to instruct the work force in the use of appropriate quality and process tools. Provides benchmark date for relative comparison of quality performance.
Supports the development and implementation of a quality system that meets the ISO and FDA 820/GMP requirements and maintains ISO 13485 certification.
Drives continuous improvement activity through the collection and analysis of data and develops corrective actions that reduce waste and support key company objectives.
Works to integrate quality objectives into manufacturing processes driving defect identification to the earliest point possible.
Supervises quality engineers and inspections processes using statistical sampling techniques and precision measuring instruments to validate conformance to customer requirements.
Verify that all production procedures have been followed and the records maintained correctly per FDA and customer guidelines.
Supports in the Internal Review Board and revises policies/procedures to ensure effectiveness.
Prepares for and represents the company with customer and regulatory representatives who conduct external audits of the corporation quality system.
Participates in the internal and external CXAPA function as part of the internal Review Board.
Directs six sigma and lean manufacturing improvement projects
Provides budget inputs and tracks actual cost taking actions to company with budgetary and strategic objectives.
Reviews customer performance metrics and implements appropriate corrective action.
Maintains and validates processes per customer directed process change guidelines.
Monitors manufacturing processes and generates documentation in support of required customer approvals for process change.
Maintains/Oversees all validate processes.
Oversees the purchase of monitoring and measurement devices and coordinates their control and calibration through established corporate systems.
Oversees new order acceptance and processing through established company procedures and develops product specific implementations relate to process flow, quality systems, and statistical process controls
Works directly with customers on dock to stock programs. Leads internal implementation of such programs.
Maintains factory metric boards and leads Quality Council.
Develops and implements actions associated with meeting corporate Quality and Delivery objectives.
Manages the calibration process in a pro-active and production sensitive manner.
Bachelor’s Degree in Management or Technical
Strong mathematics, statistics, and industrial practices, preferred for this position.
7 years of Quality Management
ASQC certification preferred
Excellent interpersonal and communication skills.