In this role, you have the opportunity to
You are responsible for
Support and facilitate the department in enabling and ensuring that medical products are produced in compliance with Philips Excellence Process Framework (PEPF), Manufacturing Products QMS as well as applicable regulations (FDA, EU-MDR, cFDA, etc. ) and standards (ISO13485, ISO14971, etc.),
Set up/Improve End-to-End processes within the organization to realize product lifecycle management and build an effective “Compliance Monitoring Platform” to manage the compliance in the different phases (project initiated, design and development, manufacturing, delivery, service, etc.)
Give guidance to Manufacturing products team and actively contributes to all aspects related to quality, process and applicable regulatory requirements
Support QMS leader to Plan, coordinates, and execute internal QMS audits to ensure compliance with internal and external requirements and to identify and implement improvement opportunities within the organization.
Execute procedures for implementing CAPAs and Complaints/Feedback and for monitoring their effectiveness. Contribute to QMS maintenance and improvement, and lead particular initiatives.
Support all QMS related trainings, provide the trainings to internal team, and build compliance knowledge succession plan
You are a part of
To succeed in this role, you should have the following skills and experience
Education: Bachelor’s engineering or science degree
Experience: Minimum 5 years of experience in Quality, Project, and Process Engineering related function is required. Experience in the medical device industry (CFDA, EM MDR, and FDA) or highly regulated industries are highly preferred.
Competency and Skills :
Familiar with Medical device regulations and standards (CFDA, 21 CFR 820, MDR, ISO13485, ISO14971)
Familiar with product lifecycle management processes
Strong interpersonal and influencing skills
Experience with working with cross-functional teams
Fluent oral and written English
In return, we offer you
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 http://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 .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .