Medical Device Quality Manager
Understand and have oversight of all Medical Device Quality systems within Norgine. Utilising matrix management design, develop and maintain a medical device compliant Quality Management system (MDQMS) that is ‘fit for purpose’ and adapts to changing business needs.
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
- Provide oversight of current and evolving Medical Device regulatory requirements to ensure the MDQMS remains current.
- Maintain up to date knowledge of laws and regulations, keeping abreast of recent changes relating to medical device standards, practices and regulations
- Act as a leader of global quality and to ensure that their actions and behaviours reflect the norm of the department at all times.
- Report to senior management through management review on the performance of the Medical Device quality management system and any need for improvement using KPIs
- Maintain awareness of customer requirements throughout the organization and ensure these are supported by the MDQMS.
- Ensure those processes needed for the Medical Device quality management system are established, implemented and maintained
- Ensure systems in place to maintain the MDQMS
- Development of globally harmonised processes for critical Medical Device business processes
- Development and maintenance of the QMS that meets Regulatory and business expectations for Medical Devices.
- Design, development and continuous review of the MDQMS to ensure its continues to meet business and regulatory expectations
- Performs and executes audits in compliance with ISO 13485, Medical Device Directive/Regulation as applicable.
- Ensure delivery of global medical device audit program to support Norgine as a distributor and legal manufacturer
- Ensure program in place to enable Norgine readiness for Notified Body audits
- Oversight of MDQMS and delivery of management review
- Design, continuously develop and maintain MDQMS so that processes are in place and supported to ensure compliance with regulatory requirements impacting Norgine Medical Devices.
- Report to senior management on the performance of the medical device quality management system and any need for improvement, and ensuring the promotion of awareness of customer requirements throughout the organization.
- Support the implementation of compliance improvements across the Norgine Medical Device business.
- Implement a program to enable readiness for Medical Device audits and inspection
- Host Notified Body audits of Norgine Medical devices and systems
- Provide input into post market surveillance program
- Assess Medical Device change controls to determine impact on Norgine certificates and QMS
- Maintain the Medical devices supplier list
Interact with and make reports to VP and director level across the organisation.
Influence management in a constructive way to support the Medial Device Quality System Strategy
Norgine BV management are the key stakeholder related to medical device requirements
The individual must ensure excellent teamwork within and across Norgine, both within quality and across all functions and business units.
Ability to work and lead successfully in a matrix organisation.
Ability to influence and challenge others in a constructive way.
Experience at a managerial level in a small to medium sized Medical Device organisation.
- An engineering degree or equivalent
- Excellent Knowledge and proven application of the medical device requirements
- Strong analytical skills with respect to organisational patterns, to professional and personal interactions between staff and to documented evidence.
- Experience of setting up and managing MDQMS
- Medical Device auditing experience
- Ability to present effectively to groups.
- Ability to build effective relationships (internal and external) strong influencing skills
- Excellent verbal and written communication skills, including the ability to interact effectively with different audiences.
- Excellent networker with the ability to collaborate and agree outcomes.