QA Compliance Officer
3 weeks ago
Join a pioneering organization in the Medical Device sector, dedicated to transforming healthcare through innovative solutions aimed at early disease detection.
As part of a vibrant team located in a collaborative environment, we are seeking a Quality Assurance Officer to contribute significantly to our mission. This role is essential as we strive for compliance with ISO 13485 standards.
Key Responsibilities:
- Oversee the Quality Management System (QMS), including managing Change Controls, Non-conformances, CAPAs, and Complaints.
- Drive continuous improvement initiatives within the QMS and ensure adherence to 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 team members regarding Quality protocols.
Qualifications:
- In-depth knowledge of Life Sciences.
- A minimum of 1-2 years of experience in a Quality Assurance capacity.
- Certification as a trained lead auditor (internal).
- Proven experience in executing the responsibilities listed above.
- Ability to draft quality procedures effectively.
- Exceptional presentation and communication skills.
- Capability to foster strong professional relationships.
- Experience working within a QA team, preferably in the medical devices field.
- Familiarity with Electronic Document Management Systems.
- ISO 9001 experience is essential.
- Knowledge of ISO 13485, GCP, 21CFR Part 820, 17025, and Clinical Trials is advantageous.
- Experience as a lead external auditor is highly desirable.
- Eligibility to work in the UK is required; sponsorship is not available.
Benefits:
- Comprehensive private medical insurance.
- Collaborative work environment with a hybrid model of on-site and remote work.
- Supportive and friendly workplace culture.
- Access to wellness facilities.
- Standing desks available for ergonomic support.
- Complimentary lunch every Friday.
- On-site gym facilities.
- Food truck offerings.
- Engaging social events and activities.
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