Associate Specialist, Documentation

Edwards Lifesciences (Singapore) Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading medical technology company in Singapore is looking for a Quality team member to ensure compliance with documentation standards and manage the archiving processes. The ideal candidate should hold a Bachelor's or Diploma with relevant experience and possess strong computer skills, attention to detail, and good communication abilities. You will play a key role in supporting audits, managing documentation, and engaging in continuous process improvements, contributing to the impact on patients around the world.

Qualifications

• 1 year of previous related experience with a Bachelor's Degree.
• 3 years of previous related experience with a Diploma.
• Ability to manage confidential information with discretion.

Responsibilities

• Ensure compliance with internal procedures and manage documentation.
• Assist in archiving daily activities and document retrieval.
• Participate in projects related to documentation remediation.

Skills

Good computer skills in usage of MS Office Suite

Good written and verbal communication skills

Good problem-solving and critical thinking skills

Attention to detail

Ability to interact professionally

Ability to manage competing priorities

Education

Bachelor’s Degree in related field

Diploma in related field

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensuring each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision‑making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an impact:

• Ensure compliance with internal procedures, coordinate and perform archiving and control of documentation
• Assist in managing archiving daily activities, including storage and retrieval of records to and from the off‑site storage supplier, internal document archival and retrieval process (internal & external) etc.
• Ensure orderly work and proper segregation of documents including storage and identification
• Report, coordinate, and follow up on Annual Document Review of local site SOPs
• Scan, verify and upload documents into Product Data Management System, i.e. APEX, ARAS , Ignite etc. for completed WO, validation reports, TR/TP
• Assist in managing legacy document stored in electronic media as well as ESS and maintain the corresponding inventory list
• Conduct backroom (e.g., documentation preparation room) activities to support external audits and ensure timely response to documentation requests for auditors
• Participate/lead in projects (e.g., documentation remediation) in collaboration with team members; identify opportunities for process improvement
• Support the investigation of non‑conformities and CAPAs related to the area including root cause analysis

Other incidental duties assigned by Leadership

What you’ll need (Required):

• Bachelor’s Degree in related field with 1 year of previous related experience
• Diploma in related field with 3 years of previous related experience required

What else we look for (Preferred):

• Good computer skills in usage of MS Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem‑solving and critical thinking skills
• Good knowledge and understanding of Edwards policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
• Good understanding of medical device documentation development activities
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
• 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