Quality Manager

We are seeking an experienced Quality Manager to join our team in the IVD (In Vitro Diagnostic) industry. The ideal candidate will have a minimum of 10 years of relevant experience in the medical device manufacturing sector, with a strong background in quality management systems, regulatory compliance, and ISO standards. The Quality Manager will play a critical role in implementing, managing, and improving our company's quality management system, with a focus on IVD products and equipment.

Key Responsibilities:

1. Implement, manage, and improve the company’s quality management system, with a primary focus on IVD products and equipment.
2. Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA).
3. Lead and participate in internal audits and management reviews of the company's quality system as a key member of the quality department.
4. Manage the documentation of the company’s quality management system, ensuring compliance with relevant standards and regulations.
5. Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards.
6. Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed.
7. Update company documents in accordance with new or revised quality standards, laws, and regulations.
8. Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements.

Requirements

1. Minimum Bachelor’s degree in Science or related field.
2. ISO 13485:2016 lead auditor certification preferred.
3. Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards.
4. Strong understanding of quality management principles and practices in the medical device industry.
5. Excellent communication and interpersonal skills.
6. Ability to work collaboratively in a team environment.
7. Demonstrated problem-solving and analytical skills.
8. Attention to detail and strong organizational skills.

Benefits

• Health Care Plan (Medical)
• 401K
• Paid Time Off
• Training & Development