Senior PLM & Change Control Coordinator

Edwards Lifesciences; Singapore; On-site; SGD 39,060 - 72,540; Full time

Job summary

Edwards Lifesciences in Singapore seeks a detail-oriented documentation professional to support change control and product lifecycle management within our global manufacturing network. You will review change packages, update records in PLM, generate ECRs, assist audits, and help train teams.

A Diploma with 3 years' experience in medical device documentation is required, along with strong MS Office skills and the ability to work independently or in a team.

Qualifications

• Diploma required with 3 years working experience in documentation related function in medical device or pharmaceutical industry.

Responsibilities

• Review change package against governing procedures and liaise with initiator to release final change package.
• Incorporate approved changes to documentation (e.g. JDE data entry; verify implementation; coordinate with initiator for business priorities).
• Identify improvement opportunities, participate in special projects, create and monitor tracking spreadsheets, and deliver assigned tasks.
• Create Enterprise Change Requests (ECR) in PLM and provide basic content recommendations.
• Provide administrative support for audit backroom activities and respond to documentation requests during external audits.
• Assist in facilitating and delivering PLM training including training logistics.
• Provide admin support for Change Control report metrics consolidation and end-user support for PLM/Change Control activities.
• Other incidental duties related to role and audits.

Skills

MS Office

Communication skills

Independent work

Teamwork

Attention to detail

Interpersonal skills

Education

Diploma

Tools

PDM

PLM

Job description

Edwards Lifesciences in Singapore seeks a detail-oriented documentation professional to support change control and product lifecycle management within our global manufacturing network. You will review change packages, update records in PLM, generate ECRs, assist audits, and help train teams.

A Diploma with 3 years' experience in medical device documentation is required, along with strong MS Office skills and the ability to work independently or in a team.