Quality Management Systems Specialist
6 days ago
Biotech Healthcare is seeking a highly skilled Quality Management Systems Specialist to join their team.
About the RoleThis exciting opportunity involves supporting the implementation, maintenance, and continual improvement of the Quality Management System (QMS) in line with regulatory requirements and internal standards.
The ideal candidate will have a strong understanding of applicable regulations and standards (e.g., ISO 9001, ISO 13485, cGMP) and experience in CAPA management, internal audits, non-conformance handling and complaint resolution.
Responsibilities:
- Maintain and improve the Quality Management System (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.
- 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.
- Assist in regulatory compliance activities in coordination with Regulatory Affairs.
- Ensure timely follow-up on quality issues and ensure all tasks are completed within established timelines.
Requirements:
- 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.
About Biotech Healthcare
Biotech Healthcare is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground.
Salary: $90,000 - $110,000 per year
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