Quality Assurance Specialist
hace 2 semanas
Company Overview
Edwards Lifesciences is a leading global company driving innovation in the structural heart field. With millions of patients served worldwide, each team member plays a crucial role in shaping groundbreaking technologies that improve patient outcomes and address unmet needs.
About the Role
We are seeking an Associate Specialist, Quality Compliance to join our team. As a key player in ensuring the highest standards of integrity and safety throughout the innovation process, you will collaborate with various teams to drive decision-making for product lifecycle development. This includes optimizing product development to impact patients globally with pioneering technology.
Key Responsibilities
- Fulfill applicable medical device regulations, including ISO13485 and other relevant requirements for designated complaint handling units, as well as evaluating events for reportability to regulatory bodies.
- Investigate complaints with support from higher-level team members or managers.
- Evaluate events to determine if they qualify as complaints, manage customer relationships, and expectations during the course of complaint investigation and resolution processes.
- Assess complaint information provided, conduct additional investigations as needed, and escalate accordingly.
- Evaluate complaints for Medical Device Reporting to competent authorities.
- Prepare and submit reports to Competent Authorities after review by senior team members.
- Summarize findings, formulate conclusions, and prepare final customer correspondence after review by senior team members.
- Other incidental duties may include identifying problems with processes, procedures, and practices, recommending solutions, and devising new approaches to encountered problems.
Requirements
- Bachelor's Degree in a related field, 1 year experience in complaint handling or similar roles required.
Estimated Salary: $65,000-$90,000 per annum
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