Advance Quality Engineer

Job Title

Job Description

In this role, you have the opportunity to

Developing, applying, revising, and maintaining the manufacturing quality activities.

Ensuring compliance the regulatory (FDA, CE, NMPA, PED, ASME)/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 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

• Directly reports to Manufacturing Quality Manager

To succeed in this role, you should have the following skills and experience

• Bachelor Degree Or Above, major in Mechanical & Electronic Engineering or Equivalent
• Experience of 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.
• Familiar with analytical tools, such as FMEA, process control plan
• Solid knowledge/experience in SPC, GRR & Process Capability Analysis;
• Lean, problem solving and project management skill.
• 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. 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.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.