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Quality Assurance Manager
1 month ago
Biotech Healthcare is a leading organization in the medical device, pharmaceutical, and biotech industry.
Job DescriptionExecutive QMS Role SummaryThis role is responsible for supporting the implementation, maintenance, and continual improvement of the Quality Management System (QMS) to ensure compliance with regulatory requirements and internal standards.
Key Responsibilities- Maintain and improve the QMS to ensure compliance with regulatory requirements and company policies.
- Support the creation, review, and updating of company procedures and documentation in alignment with QMS guidelines.
- Execute and monitor QMS activities, including complaint handling, non-conformance management, CAPA, documentation control, and management reviews.
- Collaborate with process owners to develop and implement necessary procedures and protocols.
- Conduct internal audits and inspections to evaluate the effectiveness of the QMS and ensure continuous improvement.
- Strong knowledge of quality management systems and relevant regulatory standards (ISO 9001, ISO 13485, GMP).
- Proficiency in quality assurance tools and methodologies such as CAPA, root cause analysis, and internal auditing.
- Excellent documentation, reporting, and record-keeping skills.
- Ability to manage multiple tasks simultaneously with a high level of attention to detail.
- Proficient in quality management software and other relevant tools.
The estimated annual salary for this position is $85,000-$110,000 based on location and experience.