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Job Description: Quality Assurance Specialist
Develops and applies sound knowledge and understanding of the QA frameworks, legislative requirements, processes, and procedures in the EMEA distribution organization. Responsible for developing and maintaining the QMS and ensuring compliance with the ISO 9001 standard.
Key Activities & Accountabilities
1. Along with the QA Manager and QA team, responsible for ensuring compliance with the ISO 9001 standard across UK&BNN sites.
2. Develop and maintain UK&BNN QMS and documentation system to ensure sites operate within approved Corporate and Regional EMEA processes and procedures.
3. 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.
4. Support annual Management Reviews of the Quality System to ensure and monitor its suitability, adequacy, and effectiveness.
5. Support a program of Internal Quality Audits covering all processes.
6. 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.
7. Assist in creation of a QMS training program. Ensure that all new staff are inducted into the requirements of the QMS related to their roles and responsibilities. Provide update training as necessary.
8. Analyse data on the effectiveness of the QMS and evaluate where continual improvements can be made, including data from monitoring, measurement, and other relevant sources.
9. Support departmental process owners to identify, implement, and document improvement opportunities.
10. Assist in creation of quality objectives for RAQA and non-RAQA departments.
11. Report to management on the performance of the QMS and any need for improvement.
Education
BSc degree in a relevant field. An advanced degree is preferred.
Experience
2-4 years of relevant experience.
1. Project support and time management skills, including writing, coordination, and execution of complex QA items.
2. Demonstrated knowledge and application of quality requirements including ISO 9001.
3. Knowledge of environmental quality standard ISO 14001 is an advantage.
4. Some technical knowledge of medical device quality requirements.
5. Ability to develop influence across the organization.
6. Coordinate and support technical and scientific QA activities.
7. Ability to act under minimal supervision and make decisions in the relevant area of competence.
8. Clearly communicate information to peers, supervisors, and stakeholders across the organization.
9. Attend meetings with regulatory agencies, internal and external audits, and other stakeholders.
10. Prepare briefings and informational documents.
11. Value diverse ideas, opinions, and insights, and apply them in the workplace.
12. Connect and relate well with people who think and act differently.
13. Embrace scrutiny and feedback as opportunities to learn and improve.
14. Prepare QA metrics for reporting purposes.
15. High attention to detail and process consciousness.
16. Fluent in English and local languages where applicable.
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