In this role, you have the opportunity to
Developing, applying, revising, and maintaining the manufacturing quality activities.
Ensuring compliance the regulatory (FDA, CE, SFDA)/standard (ISO13485) requirements are implemented correctly and followed strictly.
You are responsible for
Responsible for driving product quality improvement in operations.
Responsible for handling and determine Nonconformity products during manufacturing process.
Lead the project team to workout the control point from FMEA through control plan.
Design and Develop inspection process to cover in-process, final and package, DHR review before final release.
Contact Window to handle customer and market quality issue compliant and feedback
Responsible for Quality Data analysis and report provide by weekly/monthly/Quarterly.
Conduct Process Audit to drive continue improvement in ops.
Provide training on Quality Assurance/GMP/FDA-QSR related topics
Participate and support the Process Validation execution as needed.
Participate and supporting the external and internal Audit.
Other tasks assigned by manager.
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/ Mechanical manufacturing
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 .