Check with seller [Đồng Nai] Quality Validation Assistant Manager

Tuyển dụng, việc làm Đồng Nai Quality Validation Assistant Manager
Thông báo tuyển dụng Quality Validation Assistant Manager
Chi tiết công việc

Thu nhập:
Cạnh tranh
Loại hình:
Toàn thời gian





Chức vụ:
Nhân viên





Kinh nghiệm:
7 năm
Mô tả công việc
Mô tả Công việc
JOB SUMMARY
Supervises the Quality Validation team to allocate detailed validation work on a specific portion of a broader task assigned to experienced engineers. Duties are assigned to provide experience and familiarization with validation methods, independent thinking, and company practices and policies.
ESSENTIAL DUTIES
· Manages and provides guidance for the Quality Validation group development, effectiveness, adhering to organizational policies and processes and supporting overall business and corporate targets
· Serves as expert and main point of contact for Validation issues within area of responsibility.
· Reviews and approves relevant validation documentation as per assignment and within area of responsibility.
· Influences the organization in quality objectives, prioritization and resourcing decisions as necessary.
· Acts as an internal key contributor for validation initiatives aimed at improving product quality, business systems and compliance; may be the primary representative of validation group on projects.
· Understands FDA (CFR 820, 211, 210 and 21 CFR 11), ISO (13845 and 14971) and other regulatory requirements and validation guidance such as GHTF 2004 and FDA Process Validation Guidance 2011, ISPE GAMP5, PDA, ICH etc...
· Ensures compliance with Quality System and safe working practices.
· Plans, guides, and reviews projects and or work groups under ones control to produce the desired outcome.
· Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
Yêu cầu
Yêu Cầu Công Việc
MINIMUM QUALIFICATION REQUIREMENTS
Education
· Bachelors degree in Science or Engineering is required
· Masters degree in relevant field is preferred.
Experience
Minimum 7 years working experience with at least 5 under a regulated environment.
Skills
· In-depth knowledge of U.S. and international medical device and drugs regulations and standards (21 CFR 820 & 210, 211, 11, EU MDR and ISO 13485).
· Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, project management, coordination with cross functional team members, and support for subordinates, junior engineers, technicians, and management.
· Strong analytical and logical thinking skills and key part-taking in problem-solving in collaboration with relevant functions
· Interacts with senior level external associates on significant technical matters often requiring coordination between organizations.
· Follows technical specification requirements and provides significant input on validation procedures
· Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
· Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
· Demonstrated ability to communicate effectively both verbally and in writing. Good command of English language required to attend meetings with English speaking associates and to write technical documentation.
Knowledge and use of relevant PC software applications and skills to use them effectively
Quyền lợi
Laptop
Chế độ bảo hiểm
Du Lịch
Phụ cấp
Xe đưa đón
Chế độ thưởng
Chăm sóc sức khỏe
Đào tạo
Tăng lương
Nghỉ phép năm
Thông tin chung
Thu nhập: Cạnh tranh
Nơi làm việc
KCN Long Đức, xã Long Đức, Huyện Long Thành, Tỉnh Đồng Nai.
Cách thức ứng tuyển
Ứng viên nộp hồ sơ trực tuyến bằng cách bấm nút
Ứng tuyển
bên dưới:
Các thông tin được cung cấp chỉ nhằm mục đích cho người dùng tham khảo, edunet không đại diện và không có sự liên quan tới doanh nghiệp
công ty tnhh thiết bị y tế terumo việt nam
trong các hoạt động tuyển dụng. Các thông tin bản quyền, nhãn hiệu hoặc bất kỳ quyền sở hữu trí tuệ nào liên quan đến nội dung, thương hiệu hay hình ảnh doanh nghiệp này không thuộc sở hữu của edunet.
Người tìm việc cần tự xác minh thông tin trước khi ứng tuyển, giao dịch hoặc đưa ra bất kỳ quyết định nào dựa trên các nội dung này.
việc làm tuyển gấp Đồng Nai cho người đang tìm việc

Contact seller Share

Comments