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.
• 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
• Approve market specific Product Release Authorizations following confirmation of
• 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
• 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 firstname.lastname@example.org or call in confidence 086 0204322