Job Details

Regional Quality Risk and CAPA Specialist

Hampshire, United Kingdom, Permanent

Posted: 21 hours ago


We are now looking to recruit a Regional Quality Risk and CAPA Specialist as part of TÜV SÜD's MHS global quality team. The main tasks are to identify and monitor all risks that could endanger MHS accreditation / designation; to ensure correct application of TÜV SÜD Group risk policy; and the coordination and alignment of all risk management and CAPA activities within MHS.
The Successful candidate will not be required to work at our Fareham office as this role is home based.
Main Duties and Responsibilities:
* Identify and monitor risks that could endanger accreditation/designation of TÜV SÜD's MHS certification bodies.
* Review and assess risks associated with the MHS business line from a compliance and quality perspective.
* Ensure correct application of TÜV SÜD group risk policy within the MHS business line.
* Coordinate all risk management and CAPA activities within MHS, regionally and globally.
* Manage identified and emerging risks, ensuring that mitigating actions are identified, implemented, and maintained.
* Collaborate with the quality team, process owners and relevant stakeholders to ensure quality and risk mitigation measures are embedded in MHS operating procedures.
* Support and manage any key projects and change initiatives raised as a result of any risk mitigation/control or CAPA activities.
* Define CAPA proposals resulting from activities such as internal audits, external audits, quality reports, incidents, etc.
Essential Criteria / Essential Requirements:
* Hold a Bachelors' degree or equivalent.
* Significant experience in a Quality Assurance role.
* A background in the medical device, healthcare or TIC industry.
* Knowledge of ISO 17021, ISO 17065, ISO 13485, and associated standards.
* Foundational understanding of MDSAP, MDR 2017/745 and IVDR 2017/746.
* Experience with risk and CAPA management, preferably in the medical device industry.
* Experience with process management and improvement.
* Able to lead and/or perform an internal audit according to any of the above-named standards.
* Good monitoring, management, and networking skills as well as intercultural competence to work with globally active teams in lateral management.
* Independent interpretation of regulations and standards as well as the ability to quickly absorb new information and derive necessary action plans from it.
* A good team player with a positive "can-do" attitude who actively and positively engages with colleagues with a proactive approach to change and self-development.
* Ability to maintain composure and work proactively, adaptively and well under pressure, sometimes in challenging situations.
* Ability to think critically, analytically, and pragmatically.
* An excellent communicator - written, oral, instructional, presentation skills.
* Ability to handle confrontation with appropriate grace, professionalism, and firmness to manage/resolve disputes appropriately

Job Details

Hampshire, United Kingdom