• Quality Assurance is an integral aspect of the global healthcare business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of conducting Q&R Due Diligence Assessments for prospective M&A target companies.
Your main responsibilities are:
• Support the Philips Mergers & Acquisitions team on assessing the regulatory and compliance gaps during due diligence phases, conduct Q&R Due Diligence
• Perform Assessments on prospective M&A target companies
• Co-ordinate (Project Manage) Revisions to the M&A Q&R Playbook
• Evaluate feedback from M&A Playbook Users in order to identify improvements to the M&A Q&R process
• Update M&A Q&R Playbook and associated Templates / Checklists, and M&A SharePoint as required
Deliver M&A Q&R process training to Q&R community
Coordinate and track M&A Q&R activities and progress as required
• Present on Progress to the Q&R Leadership Team as required
We are looking for
• Bachelor’s degree or equivalent preferably in a scientific discipline
• Minimum of 7 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry.
• Proven experience in Quality Management System processes.
• (Lead) auditor experience
• A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance.
o This position requires an extensive knowledge of FDA QSR’s, ISO 13485, and other worldwide Quality System Regulations.
• An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
• Skill set required for the department to operate:
o Project management experience, desired
o Good communication skills written & verbal in English
o Demonstrated experience in collaborative working environments
o Experience addressing conflicts, escalation at team level to achieve desired results.
o Demonstrated experience handling deadlines, able to focus on targets
o Demonstrated experience-driving progress, taking initiative to achieve results.
Location : VB and home based