職責描述：
Be the core team of design control process and ensure product design quality.
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.
-Review technical document and product specification.
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.
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.
-Support CE and or FDA technical documents submitting.
Quality Engineering:
-Provide expert statistical support for DOE (Design of Experiments), sampling plans capability assessments hypothesis tests.
-Provide reliability/stability ives & assessment plans.
-Support risk assessment activities: FMEA, FTA.
Project Quality:
-Act as QA window and communicate with customer quality for product technical discussion.
-Facilitate new products/customer launches form quality control point of view.
任職要求：
Bachelor or above in engineering or scientific discipline
Bilingual: English/Mandarin required
Quality assertiveness and quality mindedness.
Project management – support multiple projects simultaneously.
Organizational – can synthesize information from a variety of sources
＞3 years as Design quality

The Sol-Millennium Group is dedicated to Building a Healthier Tomorrow and helping people live in a healthier world.? Our team members are committed to improve the safety and well-being of healthcare workers and their patients with the design and development of safety medical devices.????? Sol-Millennium Group is a Global Healthcare Company providing innovative products and value added services through product development, manufacturing and distribution targeting safe injections and disposal of medical devices.? Our belief that the front line professionals are critical in the development process, we continually are in touch to share knowledge, ideas with concentration on the improved functionality of injection safety which is led by our experienced Research and Development team.? The Sol-Millennium culture focuses on continuous improvement, technological innovation and customer service.

http://www.sol-m.com