Quality Manager and Head of Regional Certification - #1087264

Key Responsibilities:

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.
• Working with competent authorities (HSA)

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.
   

Key Requirements:

• 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%)