Quality Compliance Specialist (Experience As a Legal)
CTY TNHH Sysmex Việt Nam
Địa điểm làm việc: Hà Nội
Hết hạn: 23/07/2023
- Chi tiết công việc
- Giới thiệu công ty
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Mô tả công việc
Key Job Purpose :
• To be responsible for compliance matter of company
• To implement and monitor Quality Management System (QMS) process, Corrective and Preventive Action (CAPA), Quality Complaint handling form (QCHF), Field Safety Corrective Action (FSCA)/ Field Corrective Action (FCA) matters with relevant department to enhance our quality level and mitigate the risk we may have in the future.
• To be responsible for workplace safety and health
• To be responsible for handling and monitoring customers' complaint and feedback.
• To be responsible for document control management
• To supervise and correct procedures and process management to departments.
• To look for collaboration with all departments to improve continuously procedures.
• To consult Management to establish KPIs to ensure alignment with company KPI
Summary of Functional Duties & Responsibilities:
1. Compliance matter
- Update legal requirement to relevant departments and follow-up implementation.
- Key contact to work with authorities to solve legal issues.
- Work with external lawyer to provide advice on company legal issues and business matters if required, including company license update, ....
- Provide internal advisory services to the business units and departments within the Company.
- Provide commercial legal support to all departmental projects and job functions.
- Establish best practices for executive team to manage risk in including development of legal toolkits, contract templates and to deliver training to departments and teams on operation-related legal and regulatory topics. Acts as an internal advisor in response to all legal policies, process inquiry.
- Assist in review commercial documents including contracts, statements, and board resolutions, and participate in negotiation of agreements and other legal documents, such as vendor contract, customer contract, etc. if required.
2. ISO 9001: Quality Management System
- Maintain the QMS and EMS to meet the requirements of the latest ISO9001
- Perform, monitor Internal Audits according to ISO9001 requirements to ensure compliance with regulations, internal policies, and SOPs, follow up action plan to timely correct relevant findings.
- Perform, monitor Supplier Audits, Dealer Audit when necessary
- Assist in Management Review Meeting as according to ISO9001 requirements, creating management review report, follow up action plans with departments.
- Responsible for the internal CAPA process.
- Assist in quality complaint management system.
- To develop a quality strategy to enhance the company efficiency and effectiveness.
- To advise for changing existing inappropriate procedures to improve quality of implementing quality management.
3. Workplace Safety and Health (If required)
- Maintain and update the risk registers for office.
- Establish and implement work safety procedures for office.
- To ensure compliance to all necessary regulations such as poison license, hazardous substance license.
- Establish and implement work safety procedures for office
4. Handle and monitor Quality Complaint handling form (QCHF)
- Handle customer complaint and follow up and monitor Customer Satisfaction
- Conduct customer survey, creating report
- When the complaint is going to be the quality issues, collect enough information and actual stuffs for the investigation
- Keep contact with the complaint sender by closing the issues.
- Explain the conclusion effectively and timely until closed by the customer/business partner, not spare any effort to be customer satisfaction
- To track, report and manage customer quality complaints together with Customer Care until settled.
- To implement FCA with Service team and business partners. In case of the reportable AE and FSCA to the authorities, lead and support Regulatory Affairs department until the case is closed.
- To support departments: Sales & Marketing, Services, Logistics, HR... to track, oversee... procedures of selling, quoting, tendering, documenting... and collaborate amongst departments to improve communication in servicing customers and comply with company regulation.
5. Document control management
- To build, issue documentation system according to ISO standard
- To create and train employees all general ISO SOPs
- To achieve ISO certificates in time
- To consult, [protected info] procedures
- To look for the collaboration with all departments to improve continuously procedures.
• To be responsible for compliance matter of company
• To implement and monitor Quality Management System (QMS) process, Corrective and Preventive Action (CAPA), Quality Complaint handling form (QCHF), Field Safety Corrective Action (FSCA)/ Field Corrective Action (FCA) matters with relevant department to enhance our quality level and mitigate the risk we may have in the future.
• To be responsible for workplace safety and health
• To be responsible for handling and monitoring customers' complaint and feedback.
• To be responsible for document control management
• To supervise and correct procedures and process management to departments.
• To look for collaboration with all departments to improve continuously procedures.
• To consult Management to establish KPIs to ensure alignment with company KPI
Summary of Functional Duties & Responsibilities:
1. Compliance matter
- Update legal requirement to relevant departments and follow-up implementation.
- Key contact to work with authorities to solve legal issues.
- Work with external lawyer to provide advice on company legal issues and business matters if required, including company license update, ....
- Provide internal advisory services to the business units and departments within the Company.
- Provide commercial legal support to all departmental projects and job functions.
- Establish best practices for executive team to manage risk in including development of legal toolkits, contract templates and to deliver training to departments and teams on operation-related legal and regulatory topics. Acts as an internal advisor in response to all legal policies, process inquiry.
- Assist in review commercial documents including contracts, statements, and board resolutions, and participate in negotiation of agreements and other legal documents, such as vendor contract, customer contract, etc. if required.
2. ISO 9001: Quality Management System
- Maintain the QMS and EMS to meet the requirements of the latest ISO9001
- Perform, monitor Internal Audits according to ISO9001 requirements to ensure compliance with regulations, internal policies, and SOPs, follow up action plan to timely correct relevant findings.
- Perform, monitor Supplier Audits, Dealer Audit when necessary
- Assist in Management Review Meeting as according to ISO9001 requirements, creating management review report, follow up action plans with departments.
- Responsible for the internal CAPA process.
- Assist in quality complaint management system.
- To develop a quality strategy to enhance the company efficiency and effectiveness.
- To advise for changing existing inappropriate procedures to improve quality of implementing quality management.
3. Workplace Safety and Health (If required)
- Maintain and update the risk registers for office.
- Establish and implement work safety procedures for office.
- To ensure compliance to all necessary regulations such as poison license, hazardous substance license.
- Establish and implement work safety procedures for office
4. Handle and monitor Quality Complaint handling form (QCHF)
- Handle customer complaint and follow up and monitor Customer Satisfaction
- Conduct customer survey, creating report
- When the complaint is going to be the quality issues, collect enough information and actual stuffs for the investigation
- Keep contact with the complaint sender by closing the issues.
- Explain the conclusion effectively and timely until closed by the customer/business partner, not spare any effort to be customer satisfaction
- To track, report and manage customer quality complaints together with Customer Care until settled.
- To implement FCA with Service team and business partners. In case of the reportable AE and FSCA to the authorities, lead and support Regulatory Affairs department until the case is closed.
- To support departments: Sales & Marketing, Services, Logistics, HR... to track, oversee... procedures of selling, quoting, tendering, documenting... and collaborate amongst departments to improve communication in servicing customers and comply with company regulation.
5. Document control management
- To build, issue documentation system according to ISO standard
- To create and train employees all general ISO SOPs
- To achieve ISO certificates in time
- To consult, [protected info] procedures
- To look for the collaboration with all departments to improve continuously procedures.
Yêu cầu
• Minimum Education Required: Bachelor's degree in law required
• Minimum Experience Required: Min 2 years experience as a legal,
prefer to Medical Device industry
• Skills and Knowledge Required:
- ISO 9001 QMS, Good understanding of general and specific Company and
commercial law,
- Workplace Safety and Health Act.
- Microsoft Office
• Attitude Required: Responsible, team player, keen to learn, good
communication skills
• Knowledge Desired but not Essential: Healthcare industry experiences with
in-vitro diagnostics (IVD)
• Travel Requirement: Flexible to respond to regional meeting/training
Key Competencies :
• Plans and organizes effectively
• Produce quality work meticulous and meet timeline
• Manage time effectively
• Communicates effectively
• Judgment - Problem Solving
• Customer Orientation
• Collaborates with others and teamwork
• Minimum Experience Required: Min 2 years experience as a legal,
prefer to Medical Device industry
• Skills and Knowledge Required:
- ISO 9001 QMS, Good understanding of general and specific Company and
commercial law,
- Workplace Safety and Health Act.
- Microsoft Office
• Attitude Required: Responsible, team player, keen to learn, good
communication skills
• Knowledge Desired but not Essential: Healthcare industry experiences with
in-vitro diagnostics (IVD)
• Travel Requirement: Flexible to respond to regional meeting/training
Key Competencies :
• Plans and organizes effectively
• Produce quality work meticulous and meet timeline
• Manage time effectively
• Communicates effectively
• Judgment - Problem Solving
• Customer Orientation
• Collaborates with others and teamwork
Quyền lợi
Attractive Salary
Allowance of: Transportation
Professional, dynamic and friendly working environment
Allowance of: Transportation
Professional, dynamic and friendly working environment
Thông tin khác
Ngày Đăng Tuyển
23/06/2023
Cấp Bậc
Nhân viên
Ngành Nghề
Y tế/Chăm sóc sức khỏe, Pháp lý, QA/QC
Kỹ Năng
Quality Management System, ISO 9001, Commercial Law, Compliance, Document Control
Ngôn Ngữ Trình Bày Hồ Sơ
Tiếng Anh
23/06/2023
Cấp Bậc
Nhân viên
Ngành Nghề
Y tế/Chăm sóc sức khỏe, Pháp lý, QA/QC
Kỹ Năng
Quality Management System, ISO 9001, Commercial Law, Compliance, Document Control
Ngôn Ngữ Trình Bày Hồ Sơ
Tiếng Anh
Thông tin chung
- Ngày hết hạn: 23/07/2023
- Thu nhập: Thương lượng
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