£30000 - £34000 per annum
12 months ago
Field/Office Based UK
Hours: 40 hours per week, Full Time (Monday-Friday)
£30,000 - £34,000
A global medical devices company looking to recruit a QRC Specialist to join their Quality Assurance & Regulatory team. Dedicated and passionate organisation who pride themselves on customer service ensuring excellent care. With cultural values that reflect Passion for Life vision. They incorporate five core values in everything they do.
The role - QRC Specialist
As the QRC Specialist you will be responsible for supporting the QRC Manager and maintaining the global Quality Management System and identifying opportunities for improvement.
Build Quality into all aspects of work by maintaining compliance to all quality requirements.
As part of this job, it may be required to support QRC in other regions.
Key duties and responsibilities:
* Support in Maintaining and controlling a Quality Management System based on ISO9001 and ISO 13485.
* Assisting in the investigation of NC handling in various tracking systems and following up on the corrective actions.
* Assist in (FSCA) Field Safety Corrective Actions
* Assist in training needs to achieve or maintain necessary employee competencies
* Support in monitoring performance by gathering relevant data for the KPI's and the management reviews.
* Support activities in the quality plans so that they are carried out in a timely manner
* Support on all related CAPA's
* Participating in internal and external audits and following up on the audit findings
* Assisting in monitoring and maintaining quality and compliance targets
* Preparing and analysing information for the purpose of Management Review
* Stay alert on all regulatory changes, analyse the changes, and communicate, implement the applicable requirements
* Implementation of GetAligned and the regional RQMS
* Support in ensuring products are registered with the authorities within the required deadlines
* Support in ensuring that products are reimbursed according to local regulations
* Support in the integration or transfer of new activities with the setup of action plans
* Assist in any Regulatory changes, analyse, communicate, anticipate, and implement the applicable requirements
* Provide support for all departments within the SSUs
* Interact with the Authorities. Interlocutor in the framework of inspections of Authorities.
* Organizing and contributing to inspections.
* Evaluate non-conformities and implement appropriate corrective/preventive actions
Education & Experience
* Experience in QMS in a highly regulated industry (medical device, aerospace, defence etc.)
* Excellent knowledge of Excel, Word & Powerpoint
* SharePoint, E-learning, TrackWise experience desirable
* Knowledge of ISO standards ideally 9001/13485
* Excellent language skills in English - verbal and written
* £30,000 - £34,000
* Travel expenses paid for
* Pension 6% ER 3% EE
* Private medical
* Life assurance
* Holiday 25 days' + bank