職位描述
職位職責：
1. Policies: Know & follow the 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 of quality function:
-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, MDD, QSR & SFDA regulations.
-Partner with regulatory experts for initial regulatory review in support of design change request.
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, FTA.
任職要求：
1. Education / Degree Required: Bachelor or above in engineering or scientific discipline.
2. Job Experience: 5 years +
3. Bilingual: English/Mandarin required.
4. Team interpersonal: partnering, interaction, feedback, negotiating, training.
5. Effective team interpersonal skills and the ability to work effectively within diverse cultural environments.
6. Quality assertiveness and quality mindedness.
7. Self-managed - work with minimal supervision and can respond to complex problems on own.
8. Analytical & creative thinking.
9. Project management—support multiple projects simultaneously.
10. Organizational - can synthesize information from a variety of sources.
11. Capable - understand new concepts quickly.
12. Research— maintain on-going learning of industry, regulations.
13. Knowledge of
- Regulatory compliance: ISO, QSR, MDD & GMP
- Government, trade association, industry medical publications
- Statistics and Process Excellence Skills
- Product design and manufacturing for Medical Devices
