苏州招聘

ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标
？ Policies: Know & follow Suzhou and Franchise policies & procedures related to work activities performed in area of responsibility and ensure compliance to quality policies site-wide by all functions.
？ 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.
？ Manage QE’s to 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.
？ Verification and Validation:
？ Expert in verification and validation procedures and approaches for robust qualification of product and process designs.
？ Ensure quality approvals of plans, procedures, and reports for verification and validation activities and ensure robust justification of all protocol deviations and non-conformances.

？ Regulatory:
？ Host external audits and manage audit preparation to ensure compliant outcomes.
？ 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.
？ Escalate, as appropriate, to site and regional leadership if minimum compliance standards are not being met.
？ Quality Engineering:
？ Strong background in DOE (Design of Experiments), sampling plans, capability assessments & hypothesis tests.
？ Ensure appropriate risk assessment activities: FMEA (Failure Mode Evaluation & Analysis) & FTA (Fault Tree Analysis).
？ Direct qualification of suppliers and development of supplier control plans.
？ Ensure robust investigations and timely closure of manufacturing and field non-conformances.
？ Ensure oversight of design team activities in place 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.
？ Escalate, as appropriate, to site and regional leadership if minimum technical standards are not being met.
？ Technical Quality assessments as needed for New Business Development activities in Asia-Pacific.
？ General:
？ Drives consistency across QE teams, 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: 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:
？ Education / Degree Required: Bachelor or above in engineering or scientific discipline
？ Job Experience: 7-10 years +
？ Bilingual: English/Mandarin required
？ Supervisory experience guiding individuals, setting groups goals and objectives, and managing performance
？ Cross-functional relationship building and partnering with other functional leads
？ Effective team interpersonal skills and the ability to work effectively within diverse cultural environments.
？ Oral & written communication in Mandarin and English
？ Quality assertiveness and quality mindedness
？ Strong background in Quality System development and management
？ Extensive experience with ISO 13485/QSR Design Control standards
？ Self-managed—works independently to set goals and monitor performance
？ Analytical & creative thinking
？ Project management—support multiple projects simultaneously
？ Strong problem-solving skills and able to set priorities in a complex and constantly changing environment.
？ Organizational —can synthesize information from a variety of sources
？ Capable—understand new concepts quickly
？ Experience managing audits —against ISO (International Organization for Standardization), QSR (Quality Systems Regulations) & GMP (Good Manufacturing Practices) standards
？ Research— maintain on-going learning of industry, regulations
？ Expert 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

强生（苏州）医疗器材有限公司诚聘