A global medical device company in Galway is seeking an experienced Quality Manager to work within post-market surveillance
• You will contribute to planning, directing and implementing all aspects of the complaint handling activities for a wide range of our clients 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 harmonization 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.
KEY SKILLS & EXPERIENCE
• We are looking for a qualified person to Bachelors / Masters Level in a relevant Technical qualification and desirably with 9-13 years of 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 is 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 behavior.
• You are a good communicator and fluent in English, both in writing and speaking.
- Annual Bonus
- Salary DOE
Please get in touch on email@example.com for more info