Quality Assurance Specialist
2 weeks ago
Job Summary
Abbott Diabetes Care is seeking a highly skilled Quality Assurance Specialist to join our Global Centre of Excellence for Medical Devices in Witney, Oxfordshire. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our medical devices, including glucose monitoring systems.
Key Responsibilities
- Support the CAPA process for the Witney Site, ensuring timely and effective resolution of quality issues.
- Project manage Non-conformances, Potential non-conformances, and Deviations within agreed timelines, ensuring compliance with regulatory requirements.
- Coordinate cross-functional team activities to investigate and resolve quality issues, identifying root causes and implementing corrective actions.
- Project manage CA/PA / Corrections / Effectiveness Checks within the CAPA system to agreed deliverables and timelines, ensuring quality and compliance.
- Support the tracking and trending of CAPA metrics, providing insights to improve quality and compliance.
- Investigate, document, and remediate Quality issues that arise, communicating and escalating as required.
- Deliver the quality message around site through team training, presentations, and tool box talks, promoting a culture of quality and compliance.
- Support the monitoring and compliance of the Quality Management System as it applies to site Operations, ensuring adherence to regulatory requirements.
- Plan, conduct, and review inspections for all areas as per the inspection plan, communicating findings and working with area leads to implement corrective actions.
- Support Operations to make Quality/Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging, ensuring quality and compliance.
- Champion projects that enhance and promote the effectiveness and efficiency of the quality system and product quality, driving continuous improvement.
- Promote a "right first time" approach to Quality Records, ensuring accountability for functional responsibilities.
Requirements
To be successful in this role, you will need to be a decisive and solutions-oriented individual with a track record of successful achievements and accomplishments in a quality-related role in a regulated environment, such as medical devices, pharmaceutical, or healthcare manufacturing. You will also need to have excellent communication skills and sound judgment to take decisive action to resolve quality issues and provide compliant yet practical solutions.
What We Offer
As a Quality Assurance Specialist at Abbott Diabetes Care, you will have the opportunity to work in a fast-paced, dynamic, and evolving environment, driving quality and compliance in a state-of-the-art manufacturing facility. You will also have access to structured career development opportunities, competitive salaries, a defined contribution pension scheme, share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme.
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