Quality Manager

QUALITY MANAGER NEEDED!!!

About Us:

Our client is a leading international manufacturer of innovative medical devices, dedicated to improving patient outcomes worldwide. They are committed to excellence in quality and regulatory compliance, and they foster a dynamic and collaborative work environment. They are seeking a highly motivated and experienced Quality Manager to lead their quality assurance efforts and ensure the highest standards across their global operations.

Job Summary:

The Quality Manager will be responsible for overseeing and managing the company's Quality Management System (QMS) to ensure compliance with international standards and regulations, including ISO 13485, FDA 21 CFR Part 820, and other relevant requirements. This role will involve driving continuous improvement initiatives, managing audits, and leading a team of quality professionals.

Responsibilities:

• QMS Management:Develop, implement, and maintain the company's QMS in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations
• Ensure effective documentation control, including procedures, work instructions, and records
• Manage the internal audit program and lead external audits by regulatory bodies and customers
• Regulatory Compliance:Stay up-to-date with changes in relevant regulations and standards
• Ensure compliance with global regulatory requirements for medical devices
• Prepare and submit regulatory filings as required
• Continuous Improvement:Identify and implement process improvements to enhance product quality and efficiency
• Lead root cause analysis and corrective/preventive action (CAPA) investigations
• Monitor and analyze quality metrics to identify trends and areas for improvement
• Team Leadership:Manage and mentor a team of quality professionals
• Provide training and support to employees on quality-related topics
• Foster a culture of quality and continuous improvement
• Risk Management:Oversee the risk management process, including hazard analysis and risk assessments
• Ensure effective implementation of risk mitigation strategies
• Supplier Quality:Manage supplier qualification and audit programs
• Ensure supplier compliance with quality requirements
• Complaint Handling:Manage the complaint handling process, including investigations and reporting

Qualifications:

• Bachelor's degree in a scientific or engineering discipline (Master's preferred)
• Minimum of [Number] years of experience in quality management within the medical device industry
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 9001, and other relevant regulations
• Proven experience in leading and managing audits (internal and external)
• Strong understanding of risk management principles and tools
• Excellent communication, interpersonal, and leadership skills
• Strong analytical and problem-solving abilities
• Experience with international regulatory bodies
• Experience with statistical analysis
• Certifications such as ASQ Certified Quality Manager (CQM) or Lead Auditor are a plus