This is an opportunity to take ownership, responsibility, and accountability for the quality systems of a world renowned medical device manufacturer as they holistically approach the continued improvement of their multiple quality platforms.
This is a remote to be based in the UK. salary £55,000 – £70,000
- Lead overall quality management system (QMS) execution to ensure compliance with GMP, regulatory agencies, client and senior stakeholder expectations.
- Leading the corporate quality systems under ISO:13485, 21 CFR 820, and through MDSAP certification.
- Take ownership of multiple quality platforms (quality systems, design control, post market surveillance, training, clinical) and have a holistic approach towards the wider business' quality.
- Develop and maintain system for monitoring quality metrics, including post market surveillance activities.
- Lead and supervise a small team of a Document Control Specialist and Quality Specialist.
- Act autonomously with the entire QMS, being the point of contact for deviations, CAPA implementations, change controls, SOPS.
- Bachelor's in a Science, Engineering, or relevant field.
- Minimum 8 years' experience in a Quality focused position in the Medical Devices industry under ISO:13485 and MDD/MDR guidelines
- Ability to work both autonomously and collaboratively in a small company environment.
- Previous team leadership/management experience within the quality department
- Must be based in the UK
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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