Our client, a leading global medical device MNC requires a Quality Manager for one of their sites in Galway. At our Product Experience Management (PXM) group, which is part of the Galway PXM Complaint Handling and Regulatory Reporting Department, we focus on complaint handling and post market regulatory reporting activities for a wide range of products. You will lead a high performing Complaint Handling and Medical Device Regulatory reporting team, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance.
The Quality Manager will contribute to planning, directing and implementing all aspects of the complaint handling activities for a wide range of Company products.
- You will have oversight of a team responsible that ensures complete and accurate maintenance and reporting for Global Medical device reports (MDR’s).
- You will also be responsible for Key performance indicator management including the timely submission of US Medical Device Report (MDR) and EU Vigilance Reports to external regulatory agencies.
- You will manage the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
- You will also support complaint handling harmonisation initiatives with other sites globally.
- You will have oversight of support of risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
- You will manage continuous improvement activities within your team including the role out of cell operating systems and principles within the PXM department.
- You will also be responsible for People management activities and enabling the development of team members.
- We are looking for a qualified person to Bachelors / Masters Level in a relevant Technical qualification and desirably with 9-13 years’ relevant experience with a BSc and 7-11 years’ experience with a Masters.
- Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
- People management experience in leading a team is essential.
- We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams and cross site teams.
- Experience/understanding of complaint handling or CAPA processes are desirable.
- Candidates must be able to think critically and make sound decisions.
- Candidates must be focused on patient safety and customer service, set high standards, instills operational excellence, drive accountability and model ethical behaviour.
- You are a good communicator and fluent in English, both in writing and speaking.
For further information on this Quality Manager role in Galway please contact Orla Crowley on 086 0449473/ firstname.lastname@example.org
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