Philips Advance 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
Ensures that appropriate quality plans are made and a suitable quality system is in place, for both NPI’s as well as for ongoing processes manufacturing that include all stages of the manufacture of the product/system and supports Quality System design
Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems
Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.)
Review calibration plans and records, environmental controls, and training plans and records
Organize IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls
- Approve which processes need validation/re-validation after changes, and verify processes and plans/records
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.