苏州招聘

SCOPE OF THE ROLE AND BASIC PURPOSE/职位与基本目的的范围

1. This job description covers the skills & responsibilities for the R&D Senior Quality Engineer that will be located in the China R&D facility.
2. R&D Senior Quality Engineers are responsible for:

• Assisting in the development and continuous improvement of Quality Systems for China R&D in alignment with regional and franchise objectives.
• Ensuring project team compliance with the Suzhou and Franchise Quality Management Systems, government regulations & international standards requirements
• Supporting product development efforts by preparing quality plans, reviewing design plans, overseeing qualification, risk management & validation processes, and ensuring appropriate control plans are provided for design transfer

ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标

1. Policies: Know & follow Suzhou and Franchise policies & procedures related to work activities performed in area of responsibility.
2. Safety: Follow all company safety policies and other safety precautions within work area. Promote safety to all associates that enter work area.
3. Design Control
• Ensure compliance to Suzhou and Franchise Design Control procedures
• Ensure appropriate Design Inputs and Design Outputs in evidence for project and adequate documentation and traceability are provided in the Design History File.
• Leader to ensure robust verification, validation, and transfer of product designs are established
• Ensure appropriate training is in evidence for Design Teams on Design Control and Quality Systems
4. Verification and Validation
• Expert in verification and validation procedures and approaches for robust qualification of product and process designs
• Provide quality approvals of plans, procedures, and reports for verification and validation activities and ensure robust justification of all protocol deviations and non-conformances
5. Regulatory
• Provide guidance on compliance requirements for ISO, European MDD (Medical Devices Directive), FDA (Food & Drug Administration) / QSR (Quality Systems Regulations), & SFDA regulations
• Partner with regulatory experts for initial regulatory review in support of design change requests
6. Quality Engineering
• Provide expert statistical support for DOE (Design of Experiments), sampling plans, capability assessments & hypothesis tests
• Provide reliability/stability objectives & assessment plans
• Support risk assessment activities: FMEA (Failure Mode Evaluation & Analysis) & FTA (Fault Tree Analysis)
• Lead qualification of suppliers and development of supplier control plans
• Ensure robust investigations and timely closure of manufacturing and field non-conformances.
• Develop system and provide oversight of design team activities to identify critical-to-quality design features and ensure adequate control plans for product and process designs to demonstrate product is ready to market & manufacture on an ongoing basis.
7. General
• Drives consistency with other team QE’s, China and Franchise Quality Systems, & corporate Quality Systems
• Other responsibilities may be assigned & not all responsibilities listed may be assigned
8. Others
• Work Environment: Office environment
• Travel Requirements: Extensive travel regionally and internationally. This assignment will be based in the China R&D facility.
• All employees are responsible for minimizing both the environmental and health and safety effects of the work that they perform.

Required Competencies and Skills/所需的能力与技能