- Establish, maintain and continuously improve the company’s quality systems, procedures and policies
- Maintain design history files in accordance with the company’s product development process
- Liaison with the Notified Body, FDA and Competent Authorities as required
- Lead CAPA related activities and associated tasks.
- Manage company’s preventative maintenance and calibration schedules and plans.
- Ensure product inspections take place in line with company procedures, manage any Deviations, NCPs or MRBs which may arise.
- Prepare for and document company meetings such as Management Review, Post Market Surveillance and Quality Monthly Meetings.
- Manage task completion as they arise from company meetings.
- Trend all Quality Data as required, identify and implement changes or improvements to existing systems.
- Manages, plans and documents all routine product testing to ensure continued compliance of products
- Management of Internal auditing programs and vendor management activities including critical vendors audits
- Act as management representative with responsibilities as outlined in ISO 13485, clause 5.5.2
- Manage and drive project tasks to ensure timely completion of QMS project milestones.
- Support regulatory affairs activities in support of medical device product development, including clinical, preclinical, and marketing issues
- Monitor global regulatory/quality system changes, guidelines or trends, complete gap analysis plan, advise or implement changes to ensure compliance.
- Lead the integration of the EU MDR requirements into the existing ISO 13485 Quality Management System.
- Degree qualified with a minimum of 10 years’ experience in quality role of a medical device company
- Established understanding and track record of ISO 13485, 21CFR820, ISO 14971 and MDD93/42/EEC
- Ideally have knowledge of requirements of the new European Medical Devices Regulations (EU-MDR), Regulations (EU) 2017/745.
- Lead auditor certification (IRCA or ANAB)
- Experience of clinical trials or clinical investigations would be beneficial
- Strong ability to manage critical projects as part of an interdisciplinary team
- Excellent problem solving, oral and written communication skills
- High level of self-motivation and detail oriented to deliver assigned tasks
- Ability to work as part of multi-disciplinary team of clinicians, engineers and senior management
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email firstname.lastname@example.org