Make a meaningful difference to patients around the world. At every Edwards Lifesciences facility, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives.
As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. You will apply skill and dexterity in sewing tissue and non-tissue components used to produce medical devices, in accordance with regulatory and company guidelines. Your purpose-driven work will help leave a lasting and positive impact on patient lives.
How you’ll make an impact:
• Scan, verify and upload documents into archiving system, including WO (Work Orders), Protocol/Report etc.
• Review and archive Quality Records such as Qualification package, Preventive Maintenance forms, Training records, etc.
• Coordinate annual/ad-hoc external archival process, including indexing and packaging documents
• Provide administrative support for audit backroom activities and ensure timely response to documentation requests for auditors during external audits.
• Maintain Site Master Signature Log, ensuring all new employees are added and all terminated employees are removed
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
• Other incidental duties (e.g., administrative support including retrieval of documents, records destruction, tracking loan status/retention period, etc.)
What you'll need (Required):
• GCE "O" (Ordinary) Level with 1 year of working experience in documentation related function required and
• Medical device or pharmaceutical industry experience preferred
What else we look for (Preferred):
• Knowledge of Microsoft office applications
• Flexibility to work overtime as required
• Ability to read, comprehend, and write English; good communication and interpersonal skills required
• Must be able to work independently as well as in a team environment
• Good communication and interpersonal relationship skills
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
