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Quality Assurance Compliance Analyst
2 months ago
Phaidon International is seeking two dedicated Quality Assurance Specialists with a strong background in compliance duties. The selected candidates will be required to work On-Site five days a week, which is a firm requirement. The role necessitates familiarity with systems such as Trackwise, Veeva, or Quality Management Systems (QMS).
Key Responsibilities:
- Conducts thorough investigations into complaints to identify root causes, ensuring compliance with Medical Device Reporting as per 21 CFR Part 803 and European Vigilance Reporting standards.
- Facilitates and/or coordinates complaint investigations, collaborating closely with various departments to compile comprehensive investigation reports.
Required Skills and Qualifications:
- Bachelor's Degree in a relevant field.
- A minimum of 2 years of experience in Quality Assurance, specifically in complaint handling.
- Prior experience in the medical device sector with a solid understanding of ISO 13485, FDA 21 CFR 820, and European Union MDD/MDR regulations.
- Proven ability to independently investigate complaints with minimal supervision.
- Strong analytical and problem-solving capabilities, with a knack for resolving complex issues.
- Familiarity with the fundamentals of effective technical writing.
- Exceptional communication skills, both verbal and written, along with strong interpersonal abilities.
- In-depth knowledge of Trackwise.
- Comprehensive understanding of Quality Systems, including CAPA, non-conformances, and SCARS.
We encourage interested candidates to submit their updated resumes along with any pertinent references.
Best regards,
The Phaidon International Team
