Description
I am representing a globally leading medical device manufacturer to source a Senior Quality Assurance & Regulatory Affairs Manager to manage all QA/RA functions for this growing organisation with a strong product pipeline.The QA/RA Manager will be responsible for the successful day-to-day operation of the Quality Management system, supporting and leading quality improvement initiatives. A key responsibilities will be to lead continuous improvement activities as well as develop and execute the internal audit program.
Challenging responsibilities include:
* Manage product evaluation from a quality assurance and regulation compliance standpoint.
* Manage and implement the division in the planning of the design, testing, inspection and process validations to assure quality products or components.
* Developing SOPs and procedures to maintain high quality standards.
* Communicating significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
* Prepare reports to communicate involvement and results of quality assurance activities.
* Prepare and present technical and program information to team members and management.
Qualifications
Requirements for the opportunity include:
* 7-10 years quality and/or regulatory experience in the medical device industry including European Medical Device Directive (MDD) & FDA 510(k) submissions.
* Strong work ethic - highly motivated, inspirational leader, who is able to self-train and manage.
* Excellent written and verbal communications.
* Project management skills and the ability to manage multiple priorities.
If you feel this is an opportunity that fits your skills and experience - Apply now!