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!
The Quality Systems Manager is responsible for ensuring all elements of the ZOLL Minneapolis quality system are effectively implemented and kept current with all applicable regulations. This includes risk management, CAPA, non-conforming materials, complaint handling, document control, internal audits, and management reviews. This position requires experience developing, implementing, and managing Quality Systems.
- Serve as the Management Representative for ISO and FDA purposes.
- Participate as a member of the ZOLL Minneapolis leadership team.
- Manage and maintain all aspects of the quality system to support the design, development, manufacturing and distribution of Class II and Class III medical devices. This includes oversight of the:
- Procedures and processes to ensure companywide compliance to all applicable domestic and international quality systems regulations and standards.
- Complaint handling and CAPA systems, ensuring investigations, root cause determination, implementation, and effectiveness checks are adequately addressed and
documented in a timely manner.
- Company's controlled documents and quality records.
- Non-Conforming Material Process and facilitating MRB meetings/discussions to address and resolve non-conformances related to products and processes.
- Oversee Risk Management activities for new and existing products.
- Ensure compliance with applicable FDA, ISO regulations and other regulations related to risk management.
- Lead cross functional teams in planning and conducting analyses (hazard identification, hazard analysis, failure mode effects and analysis, etc.) and mitigations.
- Maintain risk management files for all new and existing devices.
- Ensure the company maintains its external reference standards and has an effective process in place to ensure state of the art compliance with all applicable standards.
-Manage the preparation, execution and followup for internal and external Quality System audits and inspections.
- Coordinate and run Management Review meetings.
- Gather, prepare, analyze, and present data to the leadership team on the performance of the Quality Management System.
- Ensure quality system training is conducted for all new hires and updated as appropriate for current employees.
- Perform other duties as assigned.
Working knowledge of national and international quality system requirements (e.g., QSR, ISO 13485, CMDCAS) and related ISO/EN standards.
Solid experience with ISO 14971 risk management.
Strong written, verbal, critical thinking and presentation skills.
Persuasive and engaging interpersonal skills to interact with all levels of the company and oversight agencies.
Ability to multi-task with a high level of attention to detail, to meet deliverables and to think creatively.
Strategic, yet with the ability and willingness to be hands-on.
Required/Preferred Education and Experience:
Bachelor of Science in Engineering or Technical discipline; or equivalent practical experience.
A minimum of 5 years experience in Quality Systems or Quality Engineering with at least 3 years in a Quality Management role in the medical device industry.
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.