Quality Engineer

2 weeks ago

Shanghai, Shanghai, China Straumann Full time

Position Summary

This role supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development. Supports the development of and enforces internal systems and procedures to meet NMPA, ISO standards, FDA quality system regulations, and other regulatory requirements. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process. Specifies and implements new inspection equipment and instructs others in its proper use.

This position is based in our Shanghai Minhang office and reports directly to the sr. Quality Assurance Manager.

Job Responsibilities

  • Support technology transfer of processes / articles by providing complete, accurate quality documentation; this includes sampling plans, process controls, test methods, measurement techniques, and evaluation criteria throughout the manufacturing process.
  • Provide guidance to process engineering team and manufacturing team on validation methods and approach. Develops documentation strategy to ensure processes are properly validated.
  • Work with cross functional teams to plans, troubleshoot, and draft reports on equipment and process validation activities.
  • Work with cross functional teams to implement changes in accordance with internal procedures.
  • Work with cross functional teams to conduct quality investigations, identify root causes, and present potential solutions.
  • Support product registration and surveillance activities by generating supporting technical documentation.
  • Plan and perform technical studies as required.
  • Support the company Risk Management program and work with internal team on risk mitigation strategies.
  • Follow safety rules and maintains personal safety and the safety of others.
  • Follow employee policy within the company.

Qualifications:

  • Bachelor's or Master's degree in manufacturing engineering or quality related fields.
  • Must have 5+ years quality engineering experience in manufacturing field with focus on Class II or Class III medical devices.
  • Experience in planning, execution and reporting of equipment and process validations, acting as a leading role is preferred.
  • Solid quality problem investigation and solving knowledge and expertise.
  • Excellent understanding of quality principles and technologies, i.e. sampling, statistical analysis, process capability analysis, DOE, pFMEA, etc.
  • Good oral English communication.

About Straumann

The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Dental Wings, Medentika, Neodent, NUVO, Straumann and other fully/partly owned companies and partners. In collaboration with leading clinics, institutes and universities, the Group researches, develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics, biomaterials and digital solutions for use in tooth replacement and restoration or to prevent tooth loss.

Headquartered in Basel, Switzerland, the Group currently employs more than 7300 people worldwide and its products, solutions and services are available in more than 100 countries through a broad network of distribution subsidiaries and partners.

For more information, please visit: Straumann Group

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