Job Information
Philips Advanced Quality Engineer in Suzhou, China
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
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
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.