Manager, Quality

Job Summary : The Quality Manager in the field of Medical Manufacturing plays a critical role in ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of the manufacturing process. This leadership position requires expertise in quality management systems, regulatory requirements, and continuous improvement methodologies. The Quality Manager is responsible for establishing and maintaining a culture of quality excellence while ensuring the safety and efficacy of medical products.

Duties & Responsibilities

1. Quality Management System

• Develop, implement, and manage a robust quality management system (QMS) compliant with applicable regulations such as ISO 13485 and FDA guidelines.
• Ensure that all manufacturing processes and procedures adhere to the established QMS.

2. Regulatory Compliance

3. Quality Assurance

4. Supplier Quality Management

5. Risk Management

6. Quality Metrics and Reporting

7. Training and Development

8. Cross‑Functional Collaboration

9. Leadership and Team Management

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

Preferred Qualifications

Education

Physical requirements / Work Environment

This position primarily works in an office and manufacturing / production environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

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