Senior Quality Assurance Manager
2 days ago
Job Summary
We are seeking an experienced Senior Quality Assurance Manager to join our team at Biotech Healthcare. In this role, you will be responsible for supporting the implementation, maintenance, and continual improvement of our Quality Management System (QMS) in line with regulatory requirements and internal standards.
About the Role
- Maintain and improve our 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 our QMS and ensure continuous improvement.
- Lead investigations of non-conformances and customer complaints, coordinating corrective and preventive actions to resolve issues.
- Provide ongoing quality assurance support to all departments and ensure supplier quality compliance.
- Develop and deliver training programs on quality-related topics to maintain awareness of QMS requirements.
Requirements
- Bachelor's or Master's degree in Quality Assurance, Life Sciences, Engineering, or a related field.
- 3-5 years of experience in quality management systems, preferably within the medical device, pharmaceutical, or biotech industry.
- Strong understanding of applicable regulations and standards (e.g., ISO 9001, ISO 13485, cGMP).
- Experience in CAPA management, internal audits, non-conformance handling, and complaint resolution.
- Excellent communication, organizational, and analytical skills.
Additional Information
The estimated salary range for this position is between $80,000 and $110,000 per year, depending on experience and qualifications.
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