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!
This individual will support procedural requirements of ZOLL's complaint handling and event reporting systems. Work in conjunction with the engineering team to maintain quality standards across products and platforms. Provide support to investigations that lead to quality improvements. Works with latitude and independence. Reports to Supervisor and/or Quality Assurance Manager.
- Supports Quality Engineers, prepares quality documentation and reports by collecting, analyzing and summarizing information and trends
- Share time providing support between Manufacturing and Post Market.
- Well versed in developing metrics with initiative towards meeting corporate and department goals
- Focuses on data
- Initiates data collection
- Coordinates data collection
- Creates reports
- Use statistical methods
- Coordinate QA meetings, meeting minutes, and agendas
- Communicate with customers and suppliers.
- Perform root cause analysis of product. Including:
- Leading investigation to establish root cause
- Coordinating failure analysis of non-conforming/defective material with vendors and outside laboratories
- Propose recommendations for further investigation or improvement driven by data, risk management and root cause analysis
- Proactively close product complaints and/or document investigation results.
- Other duties as assigned
Required/ Preferred Education and Experience:
- Knowledge of commonly used concepts, practices and procedures related to electronics technology
- Basic computer skills in a MS Windows environment. Competent with MS Office, including Excel, Access and Word
- Knowledge of FDA QSR requirements. Knowledge of Medical Device Reporting including international regulations preferred
- Must be able to communicate verbally and in writing and work effectively within a multi-disciplined organization.
- Requires 2 year degree or equivalent work experience and 6+ years related experience
Please note this job description is not designed to cover or contain a comprehensive listing ofactivities, duties, or responsibilities that are required of the employee for this job. Duties,responsibilities, and activities will be reviewed periodically as duties and responsibilities changewith 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.
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