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Quality Manager and Head of Regional Certification
2 weeks ago
**Tasks**
- QMS Implementation/ Maintenance and Regulatory Compliance
- Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with relevant standards and regulations.
- Act as Head of Certification Body for local and regional accreditations after adequate training
- Ensure adherence to best practices, streamline processes, and drive innovation in the certification procedures.
- Stay up-to-date with national and international regulatory requirements related to medical device certification and be the key contact for regional colleagues.
- Interpret and communicate regulatory changes to internal stakeholders, ensuring ongoing compliance.
- Regional Synergies Coordination
- Collaborate with regional teams to identify opportunities for synergies and standardization in certification processes.
- Enhance communication and collaboration across regions to improve efficiency and consistency in service delivery, ensuring that best practices are shared and implemented
- Internal Audits
- Plan, support, and oversee internal audits to assess the effectiveness of the QMS.
- Identify areas for improvement, implement corrective actions, and monitor their effectiveness.
- Training Coordination
- Develop and deliver training programs on QMS, regulatory requirements, and certification processes.
- Coordinate regional training sessions to ensure a well-informed and skilled workforce.
**Qualifications**
- Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Engineering).
- Proven experience in implementing and managing Quality Management Systems, preferably in the medical device industry.
- In-depth knowledge of relevant regulations and standards (e.g. ISO 17021 ISO 13485)
- Strong project management and coordination skills.
- Excellent communication and interpersonal skills to work effectively across regional teams.
- Experience in conducting internal audits and driving continuous improvement initiatives.
- Ability to adapt to changes in regulatory landscapes and proactively integrate them into existing processes.
- Travelling in the region (10%)
