An exciting opportunity has arisen in our management team for an experienced and enthusiastic quality professional to lead our quality assurance and regulatory affairs activities. As a manufacturer of Medical Devices, this is an important and responsible role and for the right candidate, would provide a very rewarding challenge.
The position would have overall responsibility for our quality management system and for compliance to the required regulatory standards for our industry. This will have responsibility for overseeing technical files to ensure they comply with industry regulations. Experience and an understanding of the requirements of ISO 13485, MDR/MDD, FDA 21 CFR 820 and cGMP would be strongly desirable and advantageous.
A key area of the role would be to take the lead in quality and regulatory audits and work closely with external audit bodies and competent authorities to demonstrate the company’s compliance. You would also head up the QMS management review on an annual basis.
You would take the lead in ensuring a successful transition from EU MDD to EU MDR requirements and would need to manage associated deadlines with this project, whilst ensuring full compliance with UK MDR requirements (and UKCA once the regulation is published).
You will take charge of our CAPA process and be responsible for the investigation of customer complaints, non-conformities and quality defects. You will also provide the final batch release sign off required for all products leaving our manufacturing site.
As the Responsible Person for QARA, you would need the following:
- Excellent oral, written and cross functional communication skills.
- Ability to prioritise and make decisions, whist showing good problem-solving ability.
- Positive attitude toward change and contribution to new ideas/ways of working.
- Strong organisational and team-working skills including commitment and flexibility.
- Excellent attention to detail.
- Sound work ethics.
In return, we offer a competitive salary and benefits package, along with the security and support that comes with being a subsidiary or a larger group. We are currently enjoying a period of exceptional growth and has exciting expansion plans on the horizon, making this an ideal time to come on board and join our friendly team.
If you are interested to learn more about this opportunity, please send your CV and covering letter. Please note that covering letters MUST be included within your CV document as these cannot be sent or received separately.