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Details

Senior Quality Manager


Reference:JCAO0418 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Manager

Senior Quality Manager



Our client a high potential start up are seeking a Senior Quality Manager to join their team. Reporting to the Director of Quality and Regulatory the Senior Quality Manager will have a minimum of eight years’ experience in a similar role in the medical device sector. The Senior Quality Manager will work with a cross functional team providing both quality and technical input to ongoing product development and post market commercial product activities. This role will offer you the flexibility to work both in on site and from home.

Role/Responsibilities:

• Manage and continuously improve Quality Management System.

• Manage and maintain a high-performance quality engineering team.

• Manage all quality related activities for device manufacturing ensuring effective and

efficient controls are implemented and maintained.

• Provide both quality and technical review of ongoing product development.

• Responsible for device history record review and product release.

• Support product verification and validation, including risk management, biocompatibility

testing, sterilization validation, usability, pre-clinical and clinical evaluations.

• Subject Matter Expert/QMS Process Owner for Document/Record Controls, Supplier

Quality, CAPA, Non-Conforming Product and Training.

• Prepare product and process quality reports.

• Manage supplier audits.

• Assist engineering in the compilation of design history files in accordance with applicable

international standards and regulations.

• Contribute to FDA / CE and other regulatory filings.

• Plan and monitor internal audit schedule.

• Direct interactions with FDA, Notified Body, other agencies and vendors during company

audits/inspections.

• Approve market specific Product Release Authorizations following confirmation of

regulatory approvals.





Skills/Experience



• A minimum of a bachelor’s degree in Life Sciences or Engineering discipline combined

with 8+ years medical device product development.

• Medical Device Quality and Design Assurance background.

• Design Verification and Validation experience.

• Risk Management, Process Validation, Master Validation Planning and Product Quality

Plan (Acceptance Activity Mapping) experience

• Quality System Auditing (preferred certification to ISO lead/internal audit)

• Fundamentals of medical device regulatory requirements relevant to design and

development activities.

• Ability to effectively communicate and collaborate with all levels of the

organization and representatives of various functional areas within the company.


For further information please contact James Cassidy james.cassidy@lifescience.ie or call in confidence 086 0204322