Quality Engineer

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 site Quality Engineering Manager.

Job Responsibilities
This position is responsible for, but not limited to, the following:

• 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.
• Works with cross functional teams to plans, troubleshoot, and draft reports on equipment and process validation activities.
• Works with cross functional teams to implement changes in accordance with internal procedures.
• Work with Quality team and 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.
• Plans and performs technical studies, including biocompatibility studies.
• Supports the company Risk Management program and works with internal team on risk mitigation strategies.
• Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area.
• Accurately records and reports of information as required.
• Follows employee policy within the company.

Qualifications

• Bachelor's degree in mechanical engineering and/or manufacturing fields.
• Must have 8+ years quality engineering experience in medical device manufacturing field with focus on mechanical/machining/CNC(For example: Citizen machining). Experience in orthopedics or dental system is strongly preferred. Excellent understanding of mechanical manufacturing, measurement and quality assurance is strongly preferred.
• Experience in planning, execution and reporting of equipment and process validations. Experience in validation strategies for cleanrooms preferred.
• Excellent understanding of quality principles.
• Good 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

19523