Senior Quality Associate – Medical Device – Cambridge, UK
Our client is a leading life science organisation specialising in the development of medical device technologies and drug delivery systems.
The key purpose of this role is to hold responsibility for key QA processes that support both the execution and maintenance of the Quality Management system relating to device development and the generation of documentation to support the design history file, regulatory submission and ultimately GMP manufacture of medical devices and drug device combination products.
Key Responsibilities
* Responsible for the oversight of key QA processes including NCR, CAPA, Change Control and supplier management
* Work closely with project teams to ensure that projects are managed in compliance with all relevant regulatory and customer requirements and to enforce consistency and best practice across the business operations
* Fronting and presenting QMS processes during audits
* Train employees on company policies, systems, tools and techniques
* Support deviation investigation, determine root cause and work with cross functional teams to implement corrective and preventative actions.
* Instil a culture of continuous improvement.
* Updating department SOPs for routine purposes as well as contributing new and improved ways of working within the department.
* Responsible for ensuring staff are trained and aware of the importance of data integrity and potential risk to product quality and patient safety.
* Where critical data is generated, ensure that the principles of Data Integrity are adhered to.
* Responsible for completion of own tasks within required timeframes
* Support other QA activities relating to the Company’s activities as required
Qualifications and Experience
* Degree qualified in a related Life Science subject
* Experience in the Medical Device or Pharmaceutical Industry
* Good understanding of the medical device development process
* Good understanding of, ISO13485, ISO14971, 21 CFR Parts 4 and 820, EU MDR and other applicable requirements
* Auditing skills and experience
* Excellent presentation skills for delivery of Quality Metrics
* Good verbal and written communication skills
* Good decision-making ability
* Uses the management chain effectively
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