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Quality Systems Officer
- Leading HealthCare Company
- Long Term Prospects
About Our Client
This is an entrepreneurial business that have created a great infrastructure across their sites & are investing in the development of their pharmaceutical & medical devices. As they are passionate about being market leaders in terms of product range & quality, this Quality Systems Officer position will be an integral part of their ongoing journey.
As the Quality Systems Officer you will be leading the change management process, establishing and maintaining the Design History File.
Key Responsibilities will include:
- Supporting deviations and non-conformances in co-ordination with key third party organisations.
- Overseeing the change management process ensuring that all raised change requests (by all third parties) are logged, assessed & addressed in an appropriate manner.
- Support the assessment of change requests or modifications to the device design documents or production and assembly processes.
- Ensure procedures and processes are followed to maintain the relevant Design History File and associated documentation with respect to change management activities.
- Ensure appropriate quality processes and records are set-up and maintained in all suppliers and outsourced activity providers to ensure compliance with company procedures, GMPs and Device guidelines.
- Support the quality systems and processes to ensure they are effective, efficient and meet the requirements of the business.
- To support trend analysis and risk assessment processes which ensure long term supply remains compliant with specifications.
- Using tools and methodologies such as FMECA, HACCP, DMAIC, ANOVA Gauge R&R, and any other appropriate technique as required.
- Interacts with internal and external counterparts from senior management levels including Heads of Operations/Quality at suppliers, as well as day to day operational suppliers.
ALL THOUGH BASED IN CAMBRIDGE, THIS ROLE MAY INVOLVE NATIONAL & INTERNATIONAL TRAVEL AS PART OF PROJECTS.
The Successful Applicant
A Quality professional with experience managing systems within a pharmaceuticals or highly regulated industry (such as medical devices). The successful applicant will have:
- A high level of understanding & interpretation of Global GMP guidelines
- Application of ISO 14971
- An in depth understanding of Quality Management Systems (e.g.: ISO 13485, 9001 etc.)
- The ability to interact with internal and external customers and suppliers at all levels
What's on Offer
Circa £30,000 - £40,000