Manager, Quality Assurance

Location: Deerfield, WI

Resuscitation

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

Primary Purpose:

Responsible for managing complaint handling for ZOLL Medical Corporation. These responsibilities include, but are not limited to, product and customer investigations, complaint data analysis and trending, interface with regulatory agencies, complaint handling management review, MOR and vigilance reporting, and monitoring the complaint handling process for opportunities for improvement.  Perform responsibilities as it relates to meeting customers' expectations at the direction of the Customer Quality Assurance (CQA) Director in accordance with ZOLL goals , targets and objectives.

Essential Functions:

  • Ensure that quality policies and procedures are coordinated and followed in the areas of Complaint Handling and Quality Assurance .
  • Manage, develop and provide guidance to department personnel.
  • Represent ZOLL professionally in customer and regulatory meetings.
  • Establish and encourage dynamic communication within all facets of ZOLL related to the Quality Assurance program.
  • Manage Quality Assurance P&L for Department 185.
  • Develop an atmosphere to encourage motivation and continuous improvement.
  • Maintain and publish metrics for Quality Assurance monthly for worldwide distribution .
  • Ensure Quality Assurance philosophies, practices and procedures are continuously reviewed to meet medical device requirements and industry standards.
  • Traveling related to proactive customer visits, onsite investigation and supplier investigation representing Quality Assurance .
  • Assume additional responsibilities at the discretion of the reporting manager.

Skills Requirements:

  • Proficient at problem solving.
  • Excellent verbal & written communication skills.
  • Ability to lead discussions and meetings effectively.
  • Ability to meet objectives, prioritize and execute strategies in a timely manner.
  • Exceptional organizational skills and the ability to schedule tactically.

Required/Preferred Education and Experience:

  • Four year technical degree (BSEE preferred), accredited management certification or equivalent work experience .
  • 7-10+ years in a responsible quality assurance medical device environment.
  • 5+ years management experience.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity.  Essential and marginal job functions are subject to modification.

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990