Director, Quality Assurance

Medegen Inc. is a leading provider of medical devices, components and contract manufacturing services to the healthcare, medical device and pharmaceutical manufacturer industries. The company specializes in developing technologies in infusion therapy centered on helping hospitals drive greater clinical performance and improved patient care. 


Director shall establish, document, implement and maintain the integrity of the quality management system by maintaining its effectiveness in accordance with the requirements of ISO 13485:2003 and will be the first-line contact with all regulatory agencies.  Will provide guidance to the executive leadership in assurance of compliance and meet the industries best practices.  Responsible for regulatory compliance, training, facilitation of sponsor and regulatory audits/inspections and drive the company’s quality initiatives.

 

1. Responsible for establishing, documenting, implementing and maintaining the integrity of the Quality Management System by ensuring that quality objectives are established.

2. Responsible in providing evidence of commitment to the development and implementation of the quality management system by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements. 

3.Reviews Quality Management System at planned intervals to ensure continuing suitability, adequacy and effectiveness and reports to top management, the performance of the Quality Management System and any need for improvement.

4.Establishes and maintains control of records to provide evidence of conformity to requirements and of the effective operation of the Quality Management System.

5. Conducts management review meetings and delivers input/output on audit results, customer feedback, process performance and product conformity, status of preventive and corrective actions, follow-up actions from previous management reviews, changes that could affect the Quality Management System and recommendations for improvement.

6.Supports Research and Development efforts with pre-market approval (PMA’s) and clinical trials.

7. Direct and coordinate six sigma implementation.

8. Responsible for ensuring that all products manufactured are in accordance with company’s quality assurance program and quality/reliability standards satisfy customer specifications and expectations.

9. Develop and implement quality management strategy and plans, including resource, systems, time scales, financials, to support, contribute to, and integrate within, the organization’s annual business plan and long term strategy.

10.Develops and analyzes statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product.

11.Formulates and maintains quality and reliabillity expectancy of finished product.

12.Formulates and maintains quality control objectives and coordinates objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs.

13.Plans, promotes, and organizes training activities related to product quality and reliability.

14.Investigates and assists in implementing corrective actions regarding customer complaints.

15.Develops the overall inspection functions by directing the Quality Supervisor.  Objectives are to maintain good communciation between 3 shifts and make consistent evaluations of product.

16.Directs and coordinates final decision making for acceptance on questionable products.  This is accomplished clearly understanding customer requirements, product characterisitiecs manufacturing capabilities, and FDA guidelines.

17.Develops and implements program for continual training of inspectors.  This includes a build-in certification program for annual testing.

18. Conduct monthly meeting to summarize performance data on customer complaints and in-process scrap and plan corrective action responses.