Deskripsi Pekerjaan
Edwards Lifesciences, a global leader in patient-focused medical innovations, is seeking a dedicated and detail-oriented Senior Documentation Coordinator to join our team in Singapore. In this critical role, you will support the daily operations of the Document Control Center (DCC), ensuring that all documentation and records are managed in compliance with company quality standards and regulatory requirements. You will play a key part in change control processes, archiving, and maintaining the integrity of our quality management system.
As a Senior Coordinator, you will collaborate with cross-functional teams to facilitate document reviews, updates, and approvals. Your expertise will help streamline workflows, improve document accessibility, and uphold the highest standards of accuracy and compliance. This is an excellent opportunity for a proactive professional with a passion for quality and process improvement to contribute to life-saving innovations.
We value teamwork, continuous improvement, and a commitment to excellence. If you are ready to take the next step in your career in a dynamic and supportive environment, we encourage you to apply.
Tanggung Jawab
- Oversee the day-to-day operations of document control, including logging, tracking, and archiving documents in accordance with established procedures.
- Manage change control activities, ensuring timely review, approval, and implementation of document changes across departments.
- Maintain the document management system (DMS) to ensure accurate version control, secure storage, and easy retrieval of records.
- Support internal and external audits by providing accurate documentation and evidence of compliance.
- Collaborate with quality assurance, regulatory affairs, and operational teams to streamline documentation workflows and improve efficiency.
- Train and guide junior staff or users on document control processes and system usage.
- Generate reports on document status, metrics, and compliance indicators for management review.
- Identify opportunities for process improvements and contribute to the development of best practices in document management.
Kualifikasi
- Diploma or degree in a relevant field (e.g., Business, Life Sciences, Engineering) or equivalent work experience.
- Minimum of 3–5 years of experience in document control, quality assurance, or a regulated environment (e.g., medical devices, pharmaceuticals).
- Strong knowledge of document management systems and electronic document control software.
- Familiarity with ISO 13485, FDA QSR, or other quality standards is highly preferred.
- Excellent attention to detail and organizational skills with the ability to manage multiple priorities.
- Effective communication and interpersonal skills to collaborate with diverse teams.
- Proficient in Microsoft Office Suite (Word, Excel, Outlook) and experience with ERP systems is a plus.
- Ability to work independently, take initiative, and drive continuous improvement.