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Chief Quality Assurance Specialist
2 weeks ago
We are seeking a seasoned Quality Assurance Professional to join our team. This individual will be responsible for ensuring the highest standards of quality in the design, development, and commercialization of medical devices.
About the RoleThis is an exciting opportunity for a highly motivated and experienced Quality Engineer to drive quality initiatives across the organization. The successful candidate will have a proven track record in quality and regulatory control of medical devices, with expertise in Quality Management Systems (QMS), audit programs, and personnel training.
- Responsible for compliance with policies and procedures, as well as national and international regulations.
- Leads compliance and improvement activities associated with the quality system, including CAPA, audit programs, and personnel training.
- Applies thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
To be considered for this role, you will need:
- A degree in quality engineering, life science, or a related field.
- 3-5 years' experience in a quality assurance role in the medical device sector, preferably in an FDA/MDR regulated environment.
- Quality certification and lead auditor certification an advantage.
- In-depth knowledge of quality engineering principles, methodologies, and tools.
- Experience in QA activities associated with the design and development of medical devices.
We offer a competitive compensation package and a dynamic work environment that fosters growth and development.
