QMS Manager

Posted Jan 23, 2019
Project ID: PHILJP00019173
Eindhoven , Noord Brabant
6 months (Feb 15, 2019 - Aug 15, 2019)
40 hrs/week
Payrate range
QMS manager

Your team 
• 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
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