Quality Compliance Specialist
hace 5 días
**Job Summary**
We are seeking a highly skilled Quality Compliance Specialist to join our team at Edwards Lifesciences Gruppe. As a Quality Compliance Specialist, you will play a critical role in ensuring that our medical devices meet the highest standards of quality and regulatory compliance.
**Key Responsibilities:**
- Investigate complaints that include moderately complex scenarios, evaluating events to determine if they qualify as a complaint and managing customer relationships and expectations during the course of complaint investigation and resolution.
- Assess complaint information provided and conduct additional investigation as needed, escalating as appropriate.
- Seek information and input, and challenge as necessary, from Product Safety, Engineering, and other departments/business units for complaint investigation.
- Evaluate complaints for Medical Device Reporting to competent authorities.
- Prepare and submit reports to Competent Authorities, after review by a senior team member.
- Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions.
- Prepare and submit final customer correspondence, after review by a senior team member.
- May plan agenda for and run meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.).
**Requirements:**
- Fulfill applicable medical device regulations in the region, including ISO 13485 and other relevant requirements for designated complaint handling units.
- Evaluate events for reportability to applicable regulatory bodies.
**What You Will Achieve:**
- Contribute to the development and implementation of quality and compliance strategies that ensure the highest standards of quality and regulatory compliance.
- Collaborate with cross-functional teams to resolve complex complaints and ensure timely and effective resolution.
- Develop and maintain strong relationships with internal stakeholders, including Product Safety, Engineering, and other departments/business units.
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