Philips Senior Quality Engineer 

China, Jiangsu 

357869972

Senior Quality Engineer
Job Description

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

• Directly reports to Sr. Manufacture 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
• 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