Are you a quality professional with experience of working to ISO 13485? A market leader in sterile processing, who were established over 25 years ago,...
Are you a medical device quality professional with line management experience? A well-known pharmaceutical company are looking to add a Medical Device Quality Manager to their site in North-West London.
Your role will be to build and maintain a QMS compliant with ISO 13485.
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.
- 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 the company as a distributor and legal manufacturer
- 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