In this role, you have the opportunity to
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
You are responsible for
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
Manage activities within the CAPA process. Manage workflow in the CAPA process.
Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. Lead CAPA activities, and provide assistance in other Quality areas, as needed
Maintain a high level of expertise in current regulatory root cause investigation requirements, and serve as a resource for compliance to these requirements. Facilitate CAPA Review Board meetings
Quality Engineering responsibilities including Preview, review, and approval of Design History File, engineering change orders, product/process validation and verification protocols/reports
Participate and review design control activity.
Quality Engineering process consulting
Supports quality reliability team activities
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
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.
BS in engineering discipline or equivalent education, experience, training.
At least 7 years’ quality experience in medical device industry, including at least 3 years of hands-on CAPA management
Strong understanding of Quality System regulations (FDA, ISO13485).
Good understanding of statistical methods, quality tools and methodologies (SPC, FMEA, DOE, etc.)
Well-developed organizational and analytical skills
Proven ability to lead diverse discipline teams, understand and identify relationships and interdependencies across multiple projects
Must be fluent in both Chinese and English languages.
In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
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 at https://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video at https://youtu.be/ocnMFp1JBuM .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at https://www.careers.philips.com/professional/global/en/workingatphilips on our career website, where you can read stories from our employee blog at https://www.careers.philips.com/global/en/blog-unexpected . Once there,you can also learn about our recruitment process at https://www.careers.philips.com/global/en/recruitmentprocess , or find answers to some of the frequently asked questions at https://www.careers.philips.com/global/en/faq .