Philips Site Quality Manager in Eindhoven, Netherlands
The Director of Quality and Regulatory Affairs shall 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. The effective manager shall establish goals and objectives for each sub function, including improvement activities to assure that product quality and regulatory compliance are confirmed and maintained for site activities. Tools shall be provided to assure that the function has sufficient support to meet the goals and objectives. This person will manage in a matrix organization for a team up to 30 people (without being the line manager) Candidate must have strong interpersonal and communications skills with strong English language ability. Candidate must be articulate and able to communicate effectively with employees at all levels of the site cross functionally.
Organization, as well as with key individuals outside the organization. These outside contacts may include FDA staff, European government agencies, and other country governmental agencies. The candidate will also be required to communicate effectively to consultants, 3rd party test laboratories, and key supplier leaders.
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.
• Field Quality and Customer Advocacy and Post Market Surveillance Leadership:
- Post Market Surveillance leadership (CHU) meeting FDA and ISO13485 requirements
• Product Quality Assurance:
Development quality management
Supplier quality management
• Business Process Improvement:
- Lean implementation oversight within Q&R.
• 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).
Risk management compliance to ISO14971
• Shared Scope Responsibilities:
- 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.
This role will report to the Head of Q&R, Business Group Health & Wellness.
Matrix line reporting into ISE Site Manager
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
Depending on experience, a year salary (fulltime) between €79000,-and €102000,- (including personal benefits package)
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
We are looking for
Master degree preferred in an engineering area
Experience in Regulated industry Product Development (hardware related), preferably B2C mass products, is required.
For a minimum of 10 years working experience in Quality, Regulatory and Product Development
Experience in a regulated industry (medical device (preferred), 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 and experience
You may have to travel up to once in 3 months global and once in 3 months within Europe
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