Quality Manager

We are seeking an experienced and detail-oriented Quality Manager to oversee the quality assurance and regulatory compliance of our medical devices.

Developing, implementing, and maintaining quality management systems (QMS) in accordance with industry regulations.

Client Details

The client manufacture our own branded Single-use surgical instruments, and also provide clean room contract manufacturing services for a wide range of pharmaceutical and medical device manufacturers.

Description

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant regulatory requirements.
• Ensure compliance with Good Manufacturing Practices (GMP) and industry-specific quality standards.
• Oversee internal and external audits, including FDA, ISO, and customer audits, and drive continuous improvement initiatives based on findings.
• Lead and manage Corrective and Preventive Action (CAPA) programs, ensuring timely resolution of non-conformities.
• Implement and maintain risk management processes in accordance with ISO 14971.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, and Supply Chain, to ensure product quality and regulatory compliance throughout the product lifecycle.
• Develop and execute quality control and validation strategies for processes, equipment, and software.
• Manage supplier quality management programs, including vendor audits, qualification, and performance monitoring.
• Lead training programs on quality and compliance requirements for employees.
• Oversee documentation control, ensuring proper record-keeping, traceability, and change management in compliance with regulatory requirements.

Profile

• Bachelor's degree in Engineering, Life Sciences, or a related field. A Master's degree is a plus.

• Minimum 5-8 years of experience in a quality management role within the medical device industry.

• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and other regulatory frameworks.

• Experience with quality auditing, CAPA management, risk management (ISO 14971), and supplier quality assurance.

• Strong understanding of validation processes (IQ/OQ/PQ) and statistical quality control methods.

• Excellent problem-solving, leadership, and communication skills.

• Certification as a Lead Auditor, Six Sigma, or ASQ Certified Quality Engineer (CQE) is a plus.

Job Offer

• Competitive salary and performance-based incentives

• Comprehensive healthcare benefits

• Professional development