Quality Systems Manager Mdr

Vor 2 Tagen

Zug, Schweiz Coopers Group AG Vollzeit

Quality Systems Manager for Medical Devices

We are seeking a Quality Systems Manager to manage the Quality Systems function for a Medical Devices fast-growing business. As the Quality Systems Manager, you will be responsible for ensuring our products comply with all relevant regulatory requirements and standards,

**Responsibilities**:

- Manage and maintain the Quality Management System (QMS) for Medical Devices in compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP
- Oversee the implementation and maintenance of policies and procedures related to quality management and control, including document control, change control, risk management, supplier quality, and complaint handling
- Monitor and evaluate the effectiveness of the QMS through metrics and internal audits
- Conduct external audits of suppliers and contract manufacturers to ensure compliance with applicable regulatory requirements and quality standards
- Provide leadership and guidance to the Quality Systems team and cross-functional teams to ensure quality objectives are met and maintained
- Ensure compliance with all applicable laws, regulations, and industry standards related to Medical Devices
- Collaborate with Regulatory Affairs, R&D, Manufacturing, and other departments to ensure quality requirements are incorporated into product development, production, and post-market activities
- Participate in regulatory inspections and support resolution of any quality-related issues

**Qualifications**:

- Bachelor's or Master's degree in Engineering, Life Sciences, or related field
- Minimum of 7 years of experience in Quality Systems management within Medical Devices, including knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP
- Experience in conducting internal and external audits and supporting regulatory inspections
- Notified body experience
- Excellent communication, leadership, and problem-solving skills. Strong attention to detail and ability to prioritize tasks in fast paced environment
- LEAN or Agile certification is a plus

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