Quality Assurance Officer
2 days ago
**PE Global require a Quality Assurance Officer based in Leamington Spa, Warwickshire.**
Key Accountabilities:
- Support the QA Manager in maintaining compliance of the Quality processes and documentation at Leamington Spa and to meet the requirements.
- Support continuous improvements in the Quality Management System (QMS).
- Work with the managers and their teams to maintain all aspects of the QMS e.g. Change Controls, Non Conformities, CAPAs, Customer Complaints
- Provide support as required for all Notified Bodies/UKAS and Client audits.
- Work with other QA staff to provide all the support required by the Operations teams, e.g. Work Instruction review, report review, QA statements, training, quality record review.
- Perform internal audits according to the provided schedule.
- Perform desk-based and on-site audits of sub-contractors and suppliers.
- Provide support to ensure timely release of results and audited reports to clinicians.
- Assist in training of personnel on all aspects related to the QMS.
- Support the collection and reporting of monthly Quality KPIs.
- Maintain thorough knowledge and understanding ISO 15189 requirements, Regulatory expectations and guidance documents as these pertain to the work performed.
- At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.
Current Challenges and Opportunities:
- Support the development and implementation of a new QMS to ensure that Regulatory requirements are met whilst maximising work throughput.
- Develop and implement SOPs etc.
- Helping to train staff
- Helping to implement a “right first time” culture throughout the site
Experience/
**Requirements**:
- Significant experience of operating within ISO Quality Management Systems of operational laboratory environments.
- Experience with ‘Ideagen Qpulse’ Quality Management System would be a preference
- Experience in liaising with internal and external stakeholders on all areas of quality and compliance.
- Experience in conducting audits and hosting external auditors.
- Experience working within a laboratory setting working to relevant ISO accreditation standards; ISO 15189, ISO 17025, ISO 9001.
- A team player, with good analytical reasoning, customer focus, communication and change orientation in a fast paced environment.
Please click the link below to apply, call Miriam on or alternatively send an up to date CV to
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