Lead Quality Assurance Specialist
The primary responsibility of this role is to ensure that the company's Quality Management System (QMS) meets and exceeds all regulatory requirements. This involves overseeing the Quality Assurance, Quality Control, and Post-Market Surveillance teams.
This strategic leader will be responsible for maintaining and enhancing the QMS in alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable international standards. Key responsibilities include:
* Liaising with accreditation bodies
* Hosting regulatory audits
* Reviewing and updating the annual audit schedule
* Performing internal audits
* Closing out all action items within prescribed timelines
To excel in this position, candidates should have a degree in science, biomedical science/biotechnology, or a related discipline, and at least five years' experience managing Quality Assurance functions in a regulated environment. The ideal candidate will possess proven leadership experience, exceptional communication and interpersonal skills, strong project management capabilities, and analytical problem-solving skills.
This role offers a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of the industry.