Documentation Coordinator

2 weeks ago

Tuas, Singapore BD Full time

You are responsible for administering all activities in the document control function for Greater Asia R&D. You will provide quality system support to the department and maintain a document management system that complies with quality and regulatory requirements. In addition, you will lead continuous improvement efforts for documentation and overall site Quality system.

**Job Description

**Purpose**:
You are responsible for administering all activities in the document control function for Greater Asia R&D. You will provide quality system support to the department and maintain a document management system that complies with quality and regulatory requirements. In addition, you will lead continuous improvement efforts for documentation and overall site Quality system.

**Responsibilities**:

- Acts as Document Coordinator across all businesses.
- Maintains document archival and record retention program.
- Participates in the coordination, review, approval of new documents, and document revision.
- Ensures that documents are revised, approved, and well maintained.
- Performs review of each document submitted for change/review to ensure compliance with existing procedures.
- Develops and maintains Document Review Process.
- Ensures that all documentation is controlled and updated per established corporate, and local requirements.
- Chairs ECRO strategy meeting for all businesses; follows up on, and ensures timely completion of initiation, processing, and completion of ECROs.
- Authors Quality System documents in compliance with ISO requirements and Participates in the ongoing operations of quality System processes.
- Supports continuous improvement of the Quality Systems processes.

**Our Requirements**:

- Nitec/Diploma/Degree in any business, technical or engineering discipline.
- Minimum 2 years relevant experience in quality documentation.
- Team player with excellent interpersonal and communication skills.
- Computer proficiency with preferably sound knowledge in Microsoft word, Excel, and PowerPoint.

**Desired / Additional Skills & Knowledge**:

- Good working knowledge of medical device regulations and practices (ISO 13485 FDA, QSR, etc.)
- Experience in quality documentation in the medical device industry.
- Experience in electronic document management systems such as SAP.
- Experience in quality management system requirements and certified as ISO 13485 lead auditor.

**Culture and Benefits**
Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.

**How To Apply**

**Primary Work Location**:SGP Tuas - Tuas

**Additional Locations**:
**Work Shift**:SG Normal Office 0745-1645 (Singapore)

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