In this role, you have the opportunity to
Be part of our Quality & Regulatory Affairs organization. It concerns a highly accountable role in which you are managing the Quality Management System audits within and for the business Image Guided Therapy (IGT) Systems. As a strong communicator, you are capable of inspiring your stakeholders as well as managing internal and external relations, audits and inspections. It’s a dynamic role in which you make a difference, can drive change and add a positive contribution to our business transformation process.
You are responsible for
Plan, coordinate, and execute Quality Management Systems (QMS) audits as Audit Manager, to assess the compliance and effectiveness of the overall QMS of the business IGT Systems being audited;
Review responses to audit findings for completeness and effectiveness;
You ensure your team is following the same audit processes in alignment with Philips Quality management system;
Identify and share “Best Practices” within the business and business group;
Participate in Quality & Regulatory initiatives as a cross functional contributor;
Provide internal and external audit coaching and readiness training and support and drive external audits or inspections;
Building and managing relations with the Notified bodies and internal/external stakeholders;
Manage the pool of part-time volunteer auditors in an inspiring and clear way;
Because you know the medical device industry, you are always able to understand what is happening in the business;
You are the expert in assessing regulatory compliance to applicable local and international regulations/standards as well as internal requirements.
You are part of
Of course you will work intensively with a broad set of colleagues from different levels, expertise and geographic locations. However, in this role you are also the single person responsible for the audits in the business IGT systems. It is expected that you work very closely with your business partners and stakeholders towards substantial compliance by using the audit, training and coach philosophy. You will be part of the business quality and regulatory team. This team consists of several key functions who are driving or supporting the Philips quality and regulatory transformation. You will be reporting to the Q&R leader of IGT systems. Can you live up to these expectations and do you have the drive and passion for auditing, then you could be the person we are looking for? The team consists of 3 people who work close together with a larger R&D team of 15 people.
To succeed in this role, you should have the following skills and experience
Bachelor (or +) degree and Certified with a recognized Accreditation body (i.e. RAB-QSA / IRCA)
3-5 years of experience the medical device is required
Auditing experience (as Auditor, QMS Specialist/Manager, QA Specialist/manager etc.) in FDA environment is required
ISO 9001 OR ISO 13485 is required
Government/regulatory-body Quality System auditing/inspection experience preferred (i.e., former FDA);
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
Flexible to adapt to an ever-changing environment;
Good analytical skills and process improvement capabilities.
32 to 40 hours availability
In return, we offer you
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:
A competitive salary;
A variable bonus based on both Philips' results and personal performance;
A solid company pension scheme and an attractive health insurance package;
The opportunity to buy Philips shares and products at a discount;
A healthy work-life balance.
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 health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.