[담당업무]

Responsible to develop and plan Quality objective and relative projects and activities to ensure an effective and efficient Quality Management System in place. Responsible to capture, interpret and lead all implementation for all local Quality regulations and global requirements. Identify and evaluate Quality related processes for continuous improvement, ensuring business is in compliance with regulatory, ISO 13485 and company requirements. Develop and strengthen Quality awareness and culture to local organization through training and continuous education. Manage all communication and collaboration with local team on Quality issues.(e.g., NPI, distribution, post market activities).

Key Responsibilities:
• Lead the identification and evaluation of Quality-related process improvement. Develop and plan Quality projects and activities, Provide direction and guidance to project teams to execute tactical Quality projects and/or initiatives.
• Responsible for Quality Management in compliance with regulation and Edwards Quality requirements (e.g., ISO 13485, MFDS) including rolling out Global SOP. Oversee Quality system performance. Collaborate with local team and planning internal audit program, Quality training program and CAPA program to ensure successful achievement of Quality objectives.
• Develop 3PL quality capability and ensure product quality, including labeling, return inspection, non-conformance products disposition.
• Lead all preparation and communications with internal and external parties. Provide guidance to the business on Quality issues (e.g., NPI, Process change, Quality awareness, Customer inquiry)
• Ensure post market activities well implemented as per the requirement, including MDR, FCA. Resolve post market product quality issue, including hospital enquiry in partnership with stakeholders
• Develop supplier and dealer quality management strategies. Identify possible risks and plan all activities to enhance compliance to regulation and Edwards requirements
• Build and maintain good relationship with competent authority

Education and Experience:
• Bachelor's Degree in in related field, 10 years experience of previous related experience
• Experience working in multinational healthcare companies Preferred

Additional Skills:
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good facilitation and presentation skills
• Strong oral and written communication in English
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Recognized as an expert in own area within the organization
• Expert understanding of related aspects of Quality processes and/or systems, and regulatory requirements
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Ability to represent leadership on projects within a specific area interfacing with project managers and team
• Ability to consult in project setting within Quality specific area
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

[근무부서 및 직급/직책]

근무부서: QA
직급/직책: 이사, 부장, 팀장

[자격요건]

경력사항: 경력(10년 이상 )
학력사항: 대학교(4년)졸업 이상
직무기술: 의료기기, 제품·공정R&D