SSME CT Senior Quality Engineer

该职位来源于猎聘 SSME CT Senior Quality Engineer for QMS

Mission

• Enabling SSME CT business through ensuring and maintaining regulatory compliance of the SSME CT Quality Management Systems Responsibilities:
• Maintain and optimize a consistent Quality Management System compliant with worldwide regulations in close collaboration with internal stakeholders to meet their needs.
• Own and maintain QMS documentation lifecycle (document control).
• Coordinate internal and external audits in alignment with all departments and across different Business Lines. Drive and monitor audit follow-up actions to be completed on time.
• Maintain and optimize the SSME CT CAPA process. Drive and monitor timely CAPA implementation.
• Monitor and control non-conformance costs for SSME CT. Drive cross-functional improvements to reduce NCC.
• Define, monitor and control QMS KPIs (e.g. Quality Targets, CAPA implementation, audit execution) including reporting to various stakeholders as well as proposing and initiating improvement activities. Use quality tools and statistical/problem-solving methods to identify systemic issues and drive continuous improvement.
• Prepare Management Review and track action items.
• Plan and deliver QMS training/awareness.
• Work closely with SSME QT and CT HQ QT team to ensure alignment and efficiency.

Requirement

• At least Bachelor degree in one of the following areas: Engineering, Process Management, Quality Management
• More than 3 years working experience in Process Management, Quality Management or Regulatory Affairs
• Fluent in English (spoken and written) and proven cross-cultural working experience
• Sound professional knowledge of medical device regulations (e.g. ISO 13485/9001, China GMP, MDR, FDA QSMR)
• Proficient in quality tools and statical/problem-solving methods (e.g. 8D, 5 Whys, Ishikawa Diagram)
• Auditor Qualifications and experienced with organizing and hosting audits.
• Ability to analyze quality data and present insights.
• Project management capability to drive cross-functional deliverables with clear timelines and accountability.
• Strong facilitation skills for cross-functional investigations and senior stakeholder communication (including writing clear audit responses and CAPA justifications).
• Structured working approach and ability for risk-based task prioritization
• Assertiveness, analytical skills, decision-making ability, flexibility and good communication skills