Quality Systems Manager - Medical Device
Greene Group Industries
Port Huron
Provide leadership and management for the quality function and sustain the quality philosophy and lean culture. Establish, maintain and optimize an effective quality management system. Implement the quality plan to achieve the overall quality objectives. Enhance and improve Greene Group’s Industries' products and services through the implementation of ISO 9001/13485, problem-solving tools, prevention methods quality-at-the-source and continual improvement techniques.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Acts as ISO Management Representative.
- As management’s representative for quality, coordinates the implementation of the quality management system to cost-effectively facilitate quality and compliance. Interacts routinely with all functional areas as well as with customers, field sales, regulatory agencies, management, and suppliers.
- Communicates customer, regulatory and organizational requirements to assure product quality, contract compliance and customer satisfaction.
- Oversees the effective documentation and implementation of the quality management system to assure compliance with customer and regulatory requirements and the standards set by company policies.
- Works with the leadership team to ensure that individuals performing functions affecting quality are trained and demonstrate the appropriate skills and performance results.
- Manage/supervise department personnel, working with the Human Resource Department to ensure adequate training, scheduling, evaluation and mentoring takes place.
- Coordinates necessary plant personnel for internal, customer and third party quality system audits.
- Maintains a corrective action system to analyze and correct nonconforming conditions and complaints.
- Implements the performance measurements necessary to effectively evaluate organizational performance and trends in product quality, services, customer satisfaction and the cost of poor quality.
- Review supplier capabilities and monitor supplier quality to ensure desired levels of performance.
- Facilitate the effort to eliminate product and process defect causes by utilizing team-oriented problem solving methodology and recommending changes or solutions to problems.
- Be a technical resource to the manufacturing facility.
