Philips Advanced Quality Engineer 

China, Jiangsu, Suzhou City 

459135211

Advanced Quality Engineer
Job Description

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

Onsite roles require full-time presence in the company’s facilities.
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