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Quality Control Supervisor
2 months ago
Quality Assurance Manager
Company Overview
At Umbilical Life, we are committed to excellence in the medical device sector. We are currently looking for a Quality Assurance Manager to join our team, focusing on maintaining superior quality standards and ensuring compliance with industry regulations.
Core Responsibilities
- Oversee Quality Investigation Reports and Corrective and Preventive Action (CAPA) initiatives.
- Continuously update and maintain quality documentation, including Quality Manuals, Standard Operating Procedures (SOPs), and Audit Reports.
- Lead initiatives for process enhancements and manage the internal audit team.
- Collaborate with production, warehouse, and maintenance teams to uphold quality standards.
- Assist in the validation of sterile manufacturing processes.
- Manage and support external audit processes.
- Ensure compliance with on-site temperature monitoring.
- Validate equipment, processes, and new product introductions.
- Lead Hazard Analysis Critical Control Point (HACCP) teams to uphold food safety standards.
Performance Objectives
- Ensure adherence to all applicable regulations and standards.
- Meet Quality Site Metrics targets effectively.
- Proactively address risks and challenges.
- Manage product recalls efficiently.
- Maintain ongoing accreditation with relevant bodies (Notified Bodies, ISO, BRC, GDP, etc.).
- Achieve successful outcomes in audits conducted by customers and regulatory bodies.
Qualifications and Skills
Essential:
- A minimum of 3 years of experience in Quality Management within a regulated healthcare setting.
- Proficient understanding of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Medical Device regulations, ISO 9001, and ISO 13485.
- Strong analytical and collaborative skills.
Desirable:
- Familiarity with HACCP, BRC, ISO 14644, and ISO 14001 standards.
If you are passionate about quality assurance and ready to contribute to our mission, we encourage you to consider this opportunity.
