Title

Quality and Regulatory Affairs Director 


Location Midmark - Versailles, OH  

About the Organization Midmark Corporation brings efficient patient care to millions of people each day in the human and animal healthcare industries around the world. The most trusted name in medical, dental and veterinary healthcare equipment solutions, Midmark is committed to providing innovative products and services for the healthcare professional, integrating value-added technology into everything it does. With over 1,500 teammates worldwide, Midmark is dedicated to making a positive difference in the practice of healthcare. Headquartered in Dayton, Ohio, Midmark Corporation maintains five subsidiaries in the United States. To support international healthcare markets, it holds subsidiaries in France, India and Italy. For more information about Midmark, visit the company's Web site at midmark.com.

Be Extraordinary.
Take a chance and step outside the box. No matter how big or small the step is, make it a step towards an extraordinary career with Midmark. We want you to reach your full potential because we realize our teammates are our most valuable assets. Wherever your passions lie, you can find challenging and rewarding work at Midmark.

Our Culture is Unique.
Because we care™ is not just words but the way we live. We make a difference each day and challenge ourselves to be better than the best. Our people choose us because of our reputation for excellence and our work environment in which our values are lived every day.
 

Description

SUMMARY
This position will be responsible for the successful operation of the Quality and Regulatory Affairs organization integral to the design, manufacture, delivery, and service of our products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
 

  • Direct and manage all Quality Assurance and Regulatory Affairs functions for the corporation.
    • Establish and maintain relationships with regulators, global affiliates and key customers, both internal and external, to ensure strategic regulatory compliance in all aspects of product development and manufacturing
    • Interface with regulatory agencies during inspections and on quality issues.  Interface with customers and suppliers on quality, regulatory, technical and business issues.
  • Develop and implement global regulatory and compliance strategies
    • Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy.
    • Optimization and focus on quality during the design control process both for new and existing products.
    • Change management with a focus on standards and compliance excellence
  • Lead the corporation in the development, maintenance and use of effective quality standards.
    • Establish effective quality measurements throughout our flow paths.
    • Direct effective and efficient continuous quality and cost improvement efforts
  • Experience in the medical device manufacturing industry with a specific focus on regulatory compliance in the FDA Class I and II medical devices
  • Preparation of documentation for 510(k) regulatory submissions and approvals
  • Drive the Quality and Regulatory Affairs organization and processes to align and meet business goals.
  • Hire, train and develop QA staff and conduct Performance Reviews to assure highly effective teammates.

Travel: Moderate

 

Position Requirements

EDUCATION/EXPERIENCE
Bachelor of Science in Engineering or related degree, and/or 8+ years of current good manufacturing practice experience in the Quality and Regulatory Affairs organization including 5+ years supervisory/managerial experience.
 

 

Full-Time/Part-Time Full-Time  

Shift Days  

Travel Requirements  


This position is currently not accepting applications.

To search for an open position, please go to http://midmarkcorporation.appone.com



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