苏州招聘

Basic Requirement

Education
1. Bachelor degree or above with a medical device or pharmaceutical background.
Experience
1. A minimum 5 years experience in a quality / regulatory environment with 2 or more years in Research and Development quality area.
2. Multinational company experience is a plus.
Skill / Knowledge / Abilities
1. Familiar with GMP, GLP, QSR, MDD, ISO, 510K, etc.
2. Knowledge of In Vitro Diagnostic products.
3. Good command of English and Mandarin both verbal and writing.
4. Problem solving and priority setting.
5. Self-motivated, initiative and able to work under pressure.
6. Interpersonal skills and the ability to work effectively within diverse cultural environments.

Job Description

1. Lead Research and Development team into compliance with Design Control procedures.
2. Ensure appropriate Design Inputs and Design Outputs in evidence for project and adequate documentation and traceability are provided in the Design History File.
3. Ensure robust verification, validation, product designs and design review processes are established.
4. Ensure appropriate training is in evidence for Design Teams on Design Control and Quality Systems.
5. Provide guidance to Research and Development team on compliance with requirements for ISO 13485, European MDD, FDA / QSR, & SFDA regulations.
6. Provide support for stability studies during design phase.
7. Provide support for change control assessment to define applicable design control elements are carried out.
8. Support risk assessment activities: FMEA (Failure Mode Evaluation & Analysis) & Control Plan etc.
9. Partner with regulatory team for initial regulatory review in support of design change requests.
10. Maintain 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.

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