Biotech and Agricultural Engineering Management & Business Others Medical and Healthcare Other Science and Tech
6 – 10 Years
October 17, 2017
Director of Quality and Regulatory Affairs
In this role, you have the opportunity to
Oversee the Innovation site located in Eindhoven Quality Systems, Regulatory Affairs, Development Quality, Post Market Surveillance and Supplier Quality functions of Business Group Health & Wellness. You will establish goals and objectives for each sub function, including improvement activities, to assure compliance is confirmed and maintained for site activities.
You are responsible for
A team of 20-30 people.
Site Management Team:
Representing all quality aspects including development, product quality, supplier quality, post market surveillance, quality systems and regulatory affairs.
Development of annual strategic plans, updates and status.
Quality leader signoff of development project consolidations including project charter approvals, business reviews and product launch approvals.
Field Quality and Customer Advocacy and Post Market Surveillance Leadership:
Call rate tracking and reporting of products developed at this site (MCC only)
Projected Field Quality estimating and tracking
Call rate corrective action
Consumer Care experience management include CC service plans and systems
Post Market Surveillance leadership (CHU) meeting FDA and ISO13485 requirements
Product Quality Assurance:
Development quality management
Supplier quality management
Customer care implementation
Call rate exposure estimating
Implementation of improvements identified internally and by Royal Philips Quality Leadership Team.
Ratings and Reviews (R&R):
Local Management responsibility to drive improvement of Ratings and Reviews of products developed by the site.
Tracking and monitoring improvement plans at local level, submission to BG Leadership including updates on progress.
Business Process Improvement:
Lean implementation oversight within Q&R.
Black Belt program leadership: project identification and tracking, Green Belt training and mentoring (Need to delegate)
DFSS Blackbelt and Green belt local leadership: Monitoring BB projects, submission of names for training
Local DMAIC GB local leadership: organization of training, monitoring of projects
Quality System, Regulatory Affairs and Clinical Affairs Leadership:
Quality System Leadership via PQMS team, including ISO 9001 and ISO13485. FDA GMPs for Devices as well as country/region specific requirements (examples: CMDCAS, EU MDD/MDR).
Regulatory Affairs responsibility for products developed at the site including approvals (510K), site registration update via central Q&R.
Clinical planning and execution for projects via Clinical Competence team.
User Complaint Handling Unit process owner
Risk management compliance to ISO14971
Primary safety agency interface incl. UL, CSA, CE, etc.
Shared Scope Responsibilities:
Factory quality (shared with Operations/Purchasing)
Packaging/distribution quality (shared with SCSC NA, global packaging/distributions sites EU and ASEAN).
Service Level Agreement alignment.
Collaboration with other functions
including Innovation & Development, Marketing, Operations, Finance and Legal to assure coordinated efforts result in desired schedules and timelines for execution of new and revised existing products delivered to the market.
You are a part of
Our Business Group Health & Wellness, one of the most successful groups in Philips with double-digit growth over the last 5 years. You will be based on our High Tech Campus that is innovation-oriented, and you will help define, design and deliver all kinds of new creative propositions to meet our long-term business strategy.
To succeed in this role, you should have the following skills and experience
Master degree preferred in an engineering area;
Minimum of 10 years working experience in Quality, Regulatory and Product Development;
Experience in a regulated industry (medical device, pharma, biotech, automotive, or aerospace) is a requirement;
Strong leadership, stakeholder management and influencing skills;
Strong written and oral communications skills;
Change management driven;
Team builder with strong people management skills;
Experience with Quality Management Systems, internal/external audits, Post Market Surveillance, supplier quality and design controls is required;
Experience with ISO9001 and ISO13485 certifications by notified bodies;
Experience with FDA is a strong preference;
Experience in global Regulatory affairs and Clinical planning and execution are a preference.
In return, we offer you
A challenging, innovative environment with great opportunities for you to explore. Furthermore, our benefits are very competitive and designed around your preferences.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the
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