Quality Manager

SUMMARY OF POSITION: Responsible for meeting customer requirements associated with the production of Medical Devices beginning with receipt of an order, specifying raw material, and 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.

ESSENTIAL FUNCTIONS:

• 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 data 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 inspection 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 reviews policies/procedures to ensure effectiveness.
• Prepares for and represents the company with customer and regulatory representatives who conduct external audits of the corporate quality system.
• Participates in the internal and external CAPA functions as part of the Internal Review Board.
• Directs six sigma and lean manufacturing improvement projects.
• Provides budget inputs and tracks actual costs taking actions to comply with budgetary and strategic objectives.
• Reviews customer performance metrics and implements appropriate corrective action.
• Maintains all validated 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 validated 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 procedure and develops product specific Inspection and Control Plans based on customer blueprints and inspection criteria.
• Leads project implementations related 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.
• Occasionally provide production assistance. Provide technical guidance for all Quality functions and Process Validation assistance.
• Occasional involvement with external audits and regulatory affairs. Represent company in formal production readiness reviews with the customer.

EXPERIENCE / EDUCATION: Management or Technical Bachelor’s degree with courses in areas of mathematics, statistics, and industrial practices is preferred for this position. Seven years of equivalent Quality Management or Quality Engineering experience and ASQC certifications will be considered in lieu of a bachelor’s degree.

SKILLS: Excellent interpersonal and communication skills. Able to work with minimal supervision. Self-motivated team player. Capable in the definition, application, and utilization of statistical process control techniques and methodologies.