QMS Change Control Engineer — Quality & Compliance

BIOTRONIK APM II PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Benefits offered by this job

Entrepreneurial thinking encouraged

Global teams and projects

Professional development

Job summary

BIOTRONIK APM II PTE. LTD. is seeking a QMS Engineer to implement and maintain Quality Management Systems across Change control, Documentation/Records management, and Training.

You will interface with system houses and global teams to harmonize processes and ensure regulatory compliance. The role includes audits, CAPA handling, and leading training initiatives while driving QMS improvements and cross-site documentation control.

Qualifications

• Technical or scientific degree required.
• 3+ years in quality in regulated environments (medical devices/pharma).
• Strong documentation and communication skills.

Responsibilities

• Ensure QMS compliance with medical device regulations and standards.
• Collaborate with Global BPO Berlin on harmonized processes.
• Plan and execute internal and external audits.
• Review technical documentation during audits for compliance.
• Lead Change control and documentation management using electronic systems.
• Provide training and hypercare on document/change control and LMS.
• Report QMS KPIs and training status.

Skills

Quality systems

Documentation control

Change control

CAPA

CGMP knowledge

MS Office

Audit

Education

Technical / scientific degree

Tools

Aras PLM

SAP

MES

LMS

SharePoint

Teams

Job description

BIOTRONIK APM II PTE. LTD. is seeking a QMS Engineer to implement and maintain Quality Management Systems across Change control, Documentation/Records management, and Training.

You will interface with system houses and global teams to harmonize processes and ensure regulatory compliance. The role includes audits, CAPA handling, and leading training initiatives while driving QMS improvements and cross-site documentation control.