Quality Engineering Manager

3 weeks ago

Shanghai, China Straumann Full time

Position Summary

The Quality Engineering Manager will implement, support and sustain elements of Manufacturing Quality and the wider Quality Engineering System, and provide technical support to others.

The QE Manager will provide oversight and guidance in Manufacturing operations ensuring continuous facility and GMP compliance. Additionally the QE Manager will support product and process transfers from other sites.

The QE Manager will assign resources to support quality initiatives and will evaluate engineering elements instigating improvements where needed through problem solving and other Quality System elements.

The QE Manager is expected to maintain a close working relationship with all site functions, in addition to other global sites and R&D center to ensure compliance, best practice, and customer service levels are reached and maintained. To effectively coach and develop the department to provide continuous improvement of business results, individual and team performance.

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, 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 in its proper use.

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

 

Job Responsibilities

  • Involvement in the generation/approval/review of validation studies, capability studies, FMEA/Hazard Analysis as required.
  • To proactively manage and develop the performance of team members through performance management, training and development to meet the business needs and objectives.
  • Involvement with risk analysis, design/trasfer reviews based on manufacturing experience where necessary.
  • Ensure QE support is provided to new product transfer.
  • Collaborates with engineering, manufacturing and regulatory and works with outside suppliers where required.
  • Ensure that compliance to NMPA and international (e.g. ISO 13485/MDR/FDA) requirements are maintained. Implement and revise procedures as required to meet compliance objectives.
  • Comply with all requirements, duties and obligations under Straumann’s Quality Management System, (NCR, ECN, CAPA, complaint investigation, etc.).
  • Support manufacturing with analysis of quality data, implementing corrective action to improve product quality and identifying areas for improvement.
  • Perform statistical analysis to determine process capability, design acceptance, and analyses trends.
  • Provide input to quality team for quarterly management reviews. Present data as needed.
  • Develop quality metrics/indicators to track performance and analyses data to develop and implement improvements.
  • Lead problem identification and resolution efforts for quality related issues. Investigate issues, define and direct implementation of solutions.
  • To proactively manage direct reports in order to achieve objectives.
  • Regularly review quality controls and processes to ensure best practice and consistency across the site.

 

Qualifications:

  • Typically educated to Bachelor’s or Master’s degree in a quality, science, engineering or has equivalent work experience in relevant area.
  • Strong technical background and problem solving skills.
  • Ideally certified auditor to ISO 13485.
  • At least 8 years’ experience working in QE/QA within Medical Device Industry.
  • Detailed knowledge and experience of the GMP and ISO 13485.
  • Strong analytical and good communication skills are essential together with the ability to manage personal and team workloads to ensure high standards are maintained.
  • Excellent understanding of quality principles and technologies, i.e. sampling, statistical analysis, process capability analysis, DOE, pFMEA, etc.
  • Experience in planning, execution and reporting of process validations, acting as a leading role is preferred.
  • Good oral English communication is mandatory.

 

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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