Group: RAQA
Division: EMEA
Newbury, UK - Hybrid
Position Summary
Develops and appliessound knowledge and understanding of the QA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Responsible for developing and maintaining the QMS and ensuring compliance to the ISO9001 standard
Key Activities & Accountabilities
* Along with the QA Associate Manager and Lead Specialist, responsible for ensuring compliance with the ISO 9001 standard across UK&BNN sites.
* Develop and maintain UK&BNN QMS and documentation system to ensure sites operate within approved Corporate and Regional EMEA process and procedures.
* Ensure quality records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.
* Support annual Management Reviews of the Quality System to ensure and monitor its suitability, adequacy and effectiveness.
* Support a program of Internal Quality Audits covering all processes.
* Support continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed. Work with process owners to ensure timely CAPA investigation and closure.
* Assist in creation of a QMS training program. Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary.
* Analyse data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources
* Support departmental process owners to identify, implement and document improvement opportunities.
* Assist in creation of quality objectives for RAQA and non-RAQA departments
* Report to management on the performance of the QMS and any need for improvement.
Education
BSc degree in relevant field. Advanced Degree preferred.
Experience
2+ years relevant experience
Knowledge/Competencies
* Project support and time management skills, writing, coordination, and execution of more complex QA items.
* Demonstrated knowledge and application of quality requirements including ISO 9001
* Some technical knowledge of medical device quality requirements
* Ability to develop influence across the organization
* Coordinate and support technical and scientific QA activities.
* Ability to act under minimal supervision and take decision in the relevant area of competence
* Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and third-party distributors.
* Attend meetings with regulatory agencies, internal and external audits and other stakeholders.
* Prepares briefings and other information documents.
* Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
* Connects and relates well with people who think and act differently than oneself.
* Embraces scrutiny and accepts feedback as opportunity to learn and improve.
* Preparation of QA metrics for reporting purposes.
* High attention to detail and process consciousness.
* Strong IT skills, including Microsoft Office.
* Fluent in English (+ local language where applicable).
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