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Our client, a global scientific and medical devices organisation based in Reading are seeking to recruit an experienced Quality Coordinator, to their fast paced and growing team. This is a really exciting time to join the company as they are rapidly expanding. Based within beautiful refurbished offices with excellent benefits such as generous holidays, free parking, pension, healthcare, exceptional progression and a really friendly and supportive team and Manager.
Position Summary: This is an on-site role based in Reading to ensure compliance through the development, implementation, and maintenance of the Quality System. This includes electronic and paper-based methods for document control, training, change management, nonconformances, corrective and preventative actions, complaints, and more.
Essential Duties and Responsibilities:
- Review, prepare, execute, approve, assist with, and maintain applicable Quality System elements.
- Support integration of current and future acquisitions and maintenance of the Quality System into an electronic QMS.
- Work cross-functionally to share ideas and drive continuous improvement activities.
- Collaboratively negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy through technical support, as needed (e.g., Customer complaints/feedback).
- Develop, implement, schedule, facilitate training for the business unit and continually maintain and manage the training program for the business unit.
- Create, maintain, and distribute monthly trending reports and metrics, as required to support the visibility of the health of the quality management system.
- Accountability for all local Quality System responsibilities (initiate, evaluate/investigate, approve, and retain) Business Unit related Nonconformances, Corrective Action, Preventative Action, Document Control, Change Control, Risk management, etc.
- Ensure supplier quality assurance is in place and robust.
- Host/Co-host notified body audits and other regulatory authorities' audits.
- Reviewing production batch records to ensure that products meet release specifications.
- Update and maintain documentation, as required to ensure quality compliance.
- Contribute and lead projects and improvements from Corporate to Business Unit Levels.
- Support Business Unit processes and projects as agreed with Quality Management and the BU's General Manager.
- Additional responsibilities as required by management.
- Position may require domestic travel as this role will be responsible for quality assurance elements at multiple locations.
To be successful in this role:
Knowledge and experience of ISO 9001/13485 certified essential
Experience as a Quality professional within a Medical Device, Scientific, Industrial or Manufacturing company essential
Ability to read, analyse and interpret scientific and technical journals, financial reports and legal documents. Respond to inquiries or complaints from customers, agencies or members of the business community. Write speeches and articles for publication. Working knowledge of/Fluency in the English language (spoken and written).
Ability to apply advanced concepts such as exponents, logarithms, quadratic equations and permutations. Apply operations to such tasks as frequency distribution, test reliability/validity, variance analysis, correlation technique, sampling theory and factor analysis.
Intermediate knowledge of Word, Excel, PowerPoint, Outlook
Experience with electronic Quality Management Systems preferred.
