Lead Auditor, International Markets
In this role, you have the opportunity to
Assure international regulatory and legal compliance of the Philips quality system(s) and company-wide compliance with Philips quality policies, quality objectives, and quality standards. Responsible to perform timely, detailed, and independent internal quality management system (QMS), process-focused, to assess regulatory compliance to applicable local and international regulations/standards and Philips requirements. We are looking for somebody with a strong auditing background. You can work from home within the Netherlands 2 to 3 days a week. The office location is Eindhoven.
You are responsible for
- Planning, coordinating, and executing internal QMS and/or product-focused audits to assess the compliance and effectiveness of the overall QMS of the organizational unit(s) under audit.
- Reviewing responses to audit findings for completeness and effectiveness.
- Providing support to ensure external audit readiness and during external audits.
- Identifying at-risk business categories/sites/functions/processes in need of compliance support through the monitoring of internal and external audit reports, assessment of compliance data, and participation in organizational quality planning and management.
- Maintaining auditor competency via coaching, education, quality record review, and other methods as appropriate.
- Participating in Quality and Regulatory initiatives as a cross functional contributor and change agent for quality
You are a part of
Internal Audit team of Philips International Markets organization. at Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve. The global team consists of 2 Lead Auditors, Program Manager, a small pool of parttime auditors.
To succeed in this role, you should have the following skills and experience
- Bachelor/Master’s degree in an engineering or scientific discipline, or equivalent experience
- Qualified/Certified Lead Auditor is required
- 5+ years working in the area of Quality & Regulatory of which at least 3 years’ experience in full time auditing
- Working experience in Medical Devices or Pharma is required
- Current auditor certification with a recognized accreditation body (i.e. RAB- QSA/IRCA) is preferred
- Good understanding of global governing regulations, requirements, and standards such as 21CFR Parts 803, 806, 820, ISO 13485, ISO 9001, ISO 14971, European Medical Device Regulations is required
- An ability to successfully educate and be a change agent for Quality Management System regulations, and communicate policies to stakeholders at all levels of the organization
- Experience in corrective and preventive actions/CAPA, including root cause analysis, documenting findings/actions, and implementing actions is required
- Strong analytical and process focused thinking skills
- Strong personal skills demonstrating structured and self-organized way of working
- Ability to communicate effectively both verbally and in writing with business leads and other functional areas.
- Ability to work in a virtual team and within a global matrix organization
- Ability to travel up to 30% mainly in Europe. Note: Due to Covid pandemic, all audits are conducted remotely.
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 market conform salary
- 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
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. Learn more by watching this video.
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.
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