Quality Assurance Post-Market Engineer
ZOLL Medical Corporation
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!
NOTE: ZOLL requires COVID vaccinations subject to legal exemptions
The individual will support Post-Market activities in the areas of improvement, customer facing, and project related work. Responsible for supporting improving the effectiveness and efficiency of the overall post-market process. Lead risk management related activities for existing devices and support post-market quality by assisting with analysis and investigation of product or quality system issues.
Maintain knowledge base on new regulations and standards that affect Complaint Handling and Risk Management for medical devices.
Provide outstanding customer support with investigation updates and customer communication when required.
Take an active role in leading improvement projects with respect to the creation of tools to aid in the FDA, Health Canada, Vigilance reporting and registrar reporting for ISO 13485.
Coordinate business meetings to communicate and align the organization on customer related product issues and ensure appropriate decision making is made to initiate actions.
Understands and has the ability to perform validations (IQ, OQ, PQ)
Provide strategies to regulatory related inquiries including written response(s).
Identify opportunities or detections within the process through statistical analysis, critical thought, and development of a clear set of recommendations to the team and management for resolution
Collect, analyze, and disseminate quality data throughout the organization
Assist in developing proactive communications with Regulatory Authorities worldwide.
Meet Departmental, Corporate and Project Objectives in a timely manner in accordance with the ZOLL QMS.
Participate in areas such as Corrective and Preventive Action program and Internal/ External audits.
Working knowledge of Quality Engineering and medical device regulations (FDA
21CFR 820, 803, ISO13485, and Medical Device Directive)
Demonstrated results improving quality within an ISO/FDA manufacturing environment
Thorough understanding on how to perform risk analysis including, Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure process shortcomings are identified and appropriately addressed
Excellent interpersonal and public speaking communication skills
Proficient with Microsoft Office Suite. Access is a plus
Excellent business and technical writing a must
Must be accountable for achievement of desired results
Approximate travel is 20% (international or domestic) including traveling between ZOLL Manufacturing sites
Required/Preferred Education and Experience:
Bachelor’s degree with 5-10 years of medical device experience in Quality preferred
DMAIC Black Belt Certified or Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) preferred
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.