R&D Quality Engineer-00000RCL
Description
SCOPE OF THE ROLE AND BASIC PURPOSE
This job description covers the skills & responsibilities for the R&D Quality Engineer that will be located in the China R&D facility.
R&D 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
Policies: Know & follow Suzhou and Franchise policies & procedures related to work activities performed in area of responsibility.
Safety: Follow all company safety policies and other safety precautions within work area. Promote safety to all associates that enter work area.
Note: Requirements as listed below are designed to encompass scope of all functions of the position.
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.
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
Verification and Validation:
Understand 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, 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
Quality Engineering:
Provide 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)
Assist in qualification of suppliers and development of supplier control plans
Ensure robust investigations and timely closure of manufacturing and field non-conformances.
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.
General:
Assure 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
Others:
Work Environment: Office environment
Travel Requirements: Moderate 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.
Qualifications
Education / Degree Required: Bachelor or above in engineering or scientific discipline
Job Experience: 4 years +
Bilingual: English/Mandarin required
Team interpersonal: partnering, interaction, feedback, negotiating, training
Effective team interpersonal skills and the ability to work effectively within diverse cultural environments.
Reliability & quality engineering
Oral & written communication in Mandarin and English
Quality assertiveness and quality mindedness
Self-managed—work with minimal supervision
Analytical & creative thinking
Project management—support multiple projects simultaneously
Problem-solving & priority setting
Organizational —can synthesize information from a variety of sources
Capable—understand new concepts quickly
Auditing—against ISO (International Organization for Standardization), QSR (Quality Systems Regulations) & GMP (Good Manufacturing Practices) standards
Research— maintain on-going learning of industry, regulations
Knowledge of:
Regulatory compliance: GMP (Good Manufacturing Practices),GLP (Good Laboratory Practices), MDD (Medical Devices Directive), 510K (Pre-market Notification)
Government, trade association, industry & medical publications
Statistics and Process Excellence Skills
Product design and manufacturing for Medical Devices
Primary Location:Asia Pacific-China-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Quality (Eng)
Description
SCOPE OF THE ROLE AND BASIC PURPOSE
This job description covers the skills & responsibilities for the R&D Quality Engineer that will be located in the China R&D facility.
R&D 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
Policies: Know & follow Suzhou and Franchise policies & procedures related to work activities performed in area of responsibility.
Safety: Follow all company safety policies and other safety precautions within work area. Promote safety to all associates that enter work area.
Note: Requirements as listed below are designed to encompass scope of all functions of the position.
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.
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
Verification and Validation:
Understand 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, 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
Quality Engineering:
Provide 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)
Assist in qualification of suppliers and development of supplier control plans
Ensure robust investigations and timely closure of manufacturing and field non-conformances.
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.
General:
Assure 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
Others:
Work Environment: Office environment
Travel Requirements: Moderate 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.
Qualifications
Education / Degree Required: Bachelor or above in engineering or scientific discipline
Job Experience: 4 years +
Bilingual: English/Mandarin required
Team interpersonal: partnering, interaction, feedback, negotiating, training
Effective team interpersonal skills and the ability to work effectively within diverse cultural environments.
Reliability & quality engineering
Oral & written communication in Mandarin and English
Quality assertiveness and quality mindedness
Self-managed—work with minimal supervision
Analytical & creative thinking
Project management—support multiple projects simultaneously
Problem-solving & priority setting
Organizational —can synthesize information from a variety of sources
Capable—understand new concepts quickly
Auditing—against ISO (International Organization for Standardization), QSR (Quality Systems Regulations) & GMP (Good Manufacturing Practices) standards
Research— maintain on-going learning of industry, regulations
Knowledge of:
Regulatory compliance: GMP (Good Manufacturing Practices),GLP (Good Laboratory Practices), MDD (Medical Devices Directive), 510K (Pre-market Notification)
Government, trade association, industry & medical publications
Statistics and Process Excellence Skills
Product design and manufacturing for Medical Devices
Primary Location:Asia Pacific-China-Shanghai
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Quality (Eng)