職位描述
POSITION SUMMARY（職位概述）
? Responsible for change coordination and control for one or multiple worldwide business platforms in compliance with FDA, ISO and other applicable regulations.
? Responsible for administering all activities in the document control function. Provides quality system support to the department. Maintains a document management system that complies with quality and regulatory requirements. Leads continuous improvement efforts for documentation. Capable of taking broad work assignments requiring minimal supervision.
? Facilitates the engineering change management and material master data workflow processes, ensuring complete, consistent implementation of changes within and across business platforms and manufacturing plants worldwide.
? Possesses a broad business perspective, supporting platform core teams in global new product design and development as well as sustaining projects, combined with in-depth understanding of BD’s ERP and engineering change control environment (SAP PLM)
KEYRESPONSIBILITIES（主要職責）
1. Quality System
ü Acts as Document Coordinator in ISO 13485/FDA QSR/GMP and ISO17025 Quality System environment.
ü Acts as Engineering Change Coordinator for Documentation Management System (ECC).
ü Maintains document archival and record retention program.
ü Participates in the coordination, review, approval of new documents, and document revision. Ensure that all documentation are accurate, up-to-date, and available to appropriate personnel.
ü Ensures that documents are revised, approved, and well maintained and ensures that controlled copies are available at the authorized locations.
ü Issues and controls the numbering system of documents according to various types of document.
ü Performs review of each document submitted for change/ review to ensure compliance with existing procedures; identifies affected documentation and defines appropriate action.
ü Supports site documentation and change control users as subject matter expert (SME).
ü Leads audit support activities for the site during internal/ external audits.
ü Writes/ revises documentation procedures to support the business and quality/regulatory requirements.
ü Implements error proofing concepts throughout the document control lifecycle.
ü Authorized to destroy, or archive obsolete controlled copies of documents and responsible for the retention and storage of obsolete documents.
ü Maintains effective Quality System and procedures to ensure that all documentation are controlled and updated per established corporate, national, and international regulatory guidelines as well as Good Documentation Practices.
ü Maintains contacts with BD Division, R&D, Corporate, Medical, Quality, and Documentation Coordinators of all BD Medical manufacturing
2. Product Development
ü Ensures projects documentation complies with Quality System requirements i.e. coordinating documentation of specifications, ECOs, PDN, and forms.
ü Participates in projects to provide assistance in documentation
SKILLS AND ABILITIES（技能）
1. Degree in business, information systems, engineering or technical discipline
2. Basic understanding of quality system regulations and standards.
3. Attention to detail, careful, deliberate, disciplined, meticulous.
4. Effective organizational and planning skills.
5. Team player with excellent written and oral communication skills.
6. Knowledge of medical device regulations and practices (ISO 13485, FDA QSR, GMP etc.).
7. General SAP use, Engineering Change Management.
8. Solid computer skills in MS Office and other reporting tools.
9. Demonstrated ability to quickly learn new subject matter
10. 3-4 years relevant experience in ISO/ FDA regulated environment, with exposure to document and data control processes like engineering change control, label and copy approval, etc. is required
11. 1-2 years’ experience utilizing electronic change control tools is required
DESIRABLE（優先條件）
1. Experience of ISO17025 documentation role
2. Medical device company working experience
