Hybrid Quality Manager with Medical Device Experience at None

Our engineering company is looking for a Quality Manager with Medical Device Experience.

The plant is located in Port Huron, Michigan. It's a beautiful location near Lake Huron.  

Our client has been in business for more than 100 years. 

This project is full time with benefits. 

M-Thursday with Friday's off. 

Onsite/No remote. Relocation is offered for out of state clients. 

The Quality Manager will lead the development and implementation of quality systems, ensuring exceptional product standards, compliance, and continuous improvement to drive customer satisfaction and operational excellence at our Port Huron location; They will lead in the planning, development, implementation, communication and improvement of the Quality Management Systems, Company Policies, documentation, and customer requirements, in accordance with internal standards.

Must have medical device experience. 

1. ESSENTIAL DUTIES AND RESPONSIBILITIES: 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 the company's products and services through the implementation of ISO 9001/13485, problem-solving tools, prevention methods quality-at-the-source and continual improvement techniques. 
   1. Reports to the General Manager.
   2. Manage/supervise department personnel, working with the Human Resource Department to ensure adequate training, scheduling, evaluation and mentoring takes place.
   3. Acts as ISO Management Representative.
      1. 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.   
   4. Communicates customer, regulatory and organizational requirements to assure product quality, contract compliance and customer satisfaction. 
   5. 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. 
   6. Works with the leadership team to ensure that individuals performing functions affecting quality are trained and demonstrate the appropriate skills and performance results. 
   7. Coordinates necessary plant personnel for internal, customer and third party quality system audits. 
   8. Maintains a corrective action system to analyze and correct nonconforming conditions and complaints. 
   9. Implements the performance measurements necessary to effectively evaluate organizational performance and trends in product quality, services, customer satisfaction and the cost of poor quality. 
      1. Uses the results of performance evaluation to target improvement efforts. 
      2. Review supplier capabilities and monitor supplier quality to ensure desired levels of  performance.
      3. Facilitate the effort to eliminate product and process defect causes by utilizing team-oriented problem solving methodology and recommending changes or solutions to problems.
      4. Be a technical resource to the manufacturing facility.
      5. Responsible for all Departmental Documents in accordance with Control of Documents, DOC-03. 

1.  

   2. QUALIFICATIONS:
      2. To perform the job successfully, the incumbent will possess the abilities or aptitudes to perform each duty proficiently to meet the needs of the business. The following requirements are representative of desired levels of the knowledge, training, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
   3. REQUIREMENTS:
      3. 5 plus years of Quality, Engineering or related experience
      4. Knowledge of International Standard ISO 9001 and ISO 13485 Quality Management Systems 
      5. Knowledge of manufacturing and quality practices. 
      6. Experience with quality improvement tools and techniques (i.e. Lean, Six Sigma, Statistical Process Control and Failure Mode & Effects Analysis, Root Cause Analysis, etc.). 
      7. Demonstrated leadership, project management, facilitation and problem-solving skills. 
      8. Must demonstrate effective verbal and written communication skills in the English language. 
      9. Working knowledge and understanding of policies and procedures.
      10. Ability and willingness to work with minimal supervision.
      11. Skill in the use of a computer, in particular with WINDOWS applications.