Quality Control Analyst
4 weeks ago
The ONE Group Ltd is a prominent player in the Medical Device sector, renowned for its commitment to innovation and excellence. We are currently seeking a Quality Assurance Officer to join our dynamic team for a 12-18 month Maternity Cover. This role is pivotal in ensuring the quality and compliance of our products as we strive for ISO 13485 certification.
As part of a vibrant team of approximately 200 professionals, you will contribute significantly to our mission of enhancing patient outcomes through early disease detection.
Key Responsibilities:
- Oversee all components of the Quality Management System (QMS), including managing Change Controls, Non-conformances, Corrective and Preventive Actions (CAPAs), and Complaints.
- Drive continuous improvement initiatives within the QMS and ensure compliance through regular internal audits.
- Assist during audits conducted by notified bodies and clients.
- Analyze and report on QMS performance metrics.
- Facilitate the onboarding process for new employees regarding Quality protocols.
Qualifications:
- Comprehensive knowledge of Life Sciences principles.
- A minimum of 1-2 years of experience in a similar Quality Assurance position.
- Trained as a lead auditor (internal).
- Proficient in executing the responsibilities listed above.
- Experience in drafting quality procedures.
- Excellent presentation and communication skills, with the ability to foster strong relationships.
- Background in a QA team, preferably within the medical device industry.
- Familiarity with Electronic Document Management Systems.
- ISO 9001 experience is essential.
- Knowledge of 13485, GCP, 21CFR Part 820, 17025, and Clinical Trials is advantageous.
- Experience as a lead external auditor is highly beneficial.
- Eligibility to work in the UK; sponsorship is not available.
Benefits:
- Comprehensive private medical insurance.
- Collaborative work environment with a hybrid model: 4 days on-site and 1 day remote.
- Supportive and relaxed workplace culture that promotes teamwork.
- Access to a wellness room on-site.
- Standing desks available for ergonomic support.
- Complimentary lunch every Friday.
- On-site gym facilities.
- Food trucks offering diverse meal options.
- Engaging social activities, including unique experiences.
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