Quality Assurance Engineer, 2nd Shift
About The Position
Acute Care Technology At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won’t just have a job. You'll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL! Job Summary Responsible for supporting the Quality Assurance organization with quality improvement, supporting manufacturing, troubleshooting quality issues and monitoring quality trends; and interfacing with R&D to support new product introductions. Primary responsibilities are to prepare and maintain necessary documentation, monitor production quality performance to identify opportunities for improvements, act as a liaison between manufacturing and quality to promote quality awareness.
Requirements
- Requires a BS degree; s cience or engineering related discipline
- 3+ years related experience in a regulated environment, preferably medical device
- Proficient at problem solving
- Excellent verbal & written communication skills.
- Familiar with Statistical Analysis
- Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices
- Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
- Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.
Nice To Haves
- ASQ Certified Quality Engineer desirable
Responsibilities
- Collaborate across functions, demonstrating quality and manufacturing expertise to solve problems, interpret data, and determine next steps.
- Lead product complaint investigations, driving completion from receipt to resolution
- Complete health risk assessments from product complaints or internal product/process/system issues
- Develop and implement quality improvement programs
- Support planning, review and approval of manufacturing process validations
- Participate in change control activities for documents, manufacturing and QA/QC
- Provide technical guidance to QA and QC personnel
- Represent quality interests and concerns on project teams
- Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements
- Collect, analyze and disseminate quality data throughout the organization
- Participate in Material Review Board activities, including resolution of product nonconformities
- Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements
- Participate in Risk Management activities
- Monitor production quality performance to identify opportunities for improvements
- Engage and interface in internal and external audits providing subject matter expertise.
- Participate in the CAPA program as a trained CAPA lead
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
