In this role, you have the opportunity to
Developing, applying, revising, and maintaining the manufacturing quality activities.
Ensuring compliance the regulatory requirements are implemented correctly and followed strictly, incl. the U.S. FDA, European Medical Device Regulation, CFDA), ISO13485.
You are responsible for
Responsible for manufacturing transfer projects on QMS strategy, QA planning, QA audit, gate reviews, DHF, DMR and DHR reviews in order to fulfill regulation and QMS requirements.
Responsible for planning, execution and review of process validation activities, including IQ, OQ, PQ
Lead cross-sites/oversea sites for QMS and compliance discussion to enable the manufacturing transfer projects.
Cooperate the project team to workout the process FMEA and control point.
Conduct Process Audit to drive continue improvement in operations.
Provide training on Quality Assurance/GMP/FDA-QSR related topics
Participate and supporting the external and internal Audit.
Support CAPA, NC and complaint handling.
You are a part of
To succeed in this role, you should have the following skills and experience
Bachelor Degree Or Above, major in Mechanical & Electronic Engineering or Equivalent
5+ years Quality Engineering Experience in Medical Device/ manufacturing industry is a must. Medical device design control and risk management experience is preferred.
Familiar with medical device standard and regulatory requirement ISO13485, QSR, GMP .
Fluent English both in writing and speaking
Excellent communication and interpersonal skills;
Good training skills able to generate, following and explain detailed instructions and inspection procedures of the responsible areas accurately.
Problems solving Familiar with analytical tools, such as FMEA, process control plan
Solid knowledge/experience in SPC, GRR & Process Capability Analysis;
High morale with excellent work ethic, integrity and attitude.
Teamwork orientated, Self-motivated & able to Work Independently
In return, we offer you
We offer experiences and opportunities that add many unexpected and enriching moments to our employees’ lives. Especially when the innovative health technologies and solutions they help develop benefit their own friends and family.
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/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .