Manager of Quality Assurance
4 weeks ago
Quality Assurance Manager
Company Overview
At Umbilical Life, we are committed to excellence in the medical device sector. We are currently in search of a Quality Assurance Manager to oversee our quality management processes and ensure compliance with industry standards.
Key Responsibilities
- Oversee the management of Quality Investigation Reports and Corrective and Preventive Action (CAPA) plans.
- 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.
- Supervise and facilitate external audits.
- Monitor on-site temperature controls to ensure compliance.
- Validate equipment, processes, and new product introductions.
- Lead Hazard Analysis Critical Control Point (HACCP) teams to maintain food safety protocols.
Performance Objectives
- Ensure adherence to all applicable regulations and standards.
- Meet Quality Site Metrics targets consistently.
- Promptly address risks and issues as they arise.
- Effectively manage product recall processes.
- Maintain ongoing accreditation with relevant bodies (Notified Bodies, ISO, BRC, GDP, etc.).
- Achieve favorable audit outcomes from customers and regulatory agencies.
Qualifications and Skills
Essential:
- A minimum of 3 years of experience in Quality Management within a regulated healthcare environment.
- Proficient knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Medical Device regulations, ISO 9001, and ISO 13485.
- Demonstrated problem-solving abilities and strong teamwork orientation.
Desirable:
- Familiarity with HACCP, BRC, ISO 14644, and ISO 14001 standards.
We value individuals who are passionate about quality and eager to contribute to our mission.
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