Global QMS Engineer – Change Control & Training

BIOTRONIK; Singapore; On-site; SGD 70,000 - 110,000; Full time

Benefits offered by this job

Being entrepreneurial in global teams

Global team projects

Professional development opportunities

Job summary

BIOTRONIK is seeking a QMS Engineer in Singapore to implement and maintain Quality Management Systems across change control, documentation/records, and training. You will interface with global system houses, plan audits, review validations and DHR/DMR, and drive QMS improvements.

The role emphasizes training delivery, KPI reporting, and cross-functional collaboration. You will contribute to harmonization of global processes, support CAPA activities, and ensure compliance with CGMP and medical

Qualifications

• Technical / scientific degree in a relevant field.
• At least three years’ quality function experience in regulated environment.
• Excellent communication and interpersonal skills.
• Proficient in Microsoft Office (Word, Excel).
• Independent, yet a strong team player with good time management.
• Knowledge of CGMP and good documentation practices preferred.
• Experience in document/change control, CAPA or similar quality systems preferred.
• Attention to detail and meticulous documentation required.
• Familiarity with problem solving tools (Ishikawa, 5 Why, 8D) is a plus.
• Experience with electronic document control systems is a plus.

Responsibilities

• Ensure QMS compliance with medical devices regulations and standards.
• Interface with system houses on Change control and quality harmonization.
• Plan and execute internal and external QMS audits.
• Review technical docs ( validations, DHR, DMR) for audit readiness.
• Review audit findings and actions in the CAPA process.
• Provide training on Document and Change control Management and LMS.
• Create and update QMS training materials.
• Maintain QMS KPI reporting and training status.
• Coordinate Change Review and Change control across sites.
• Administer Change Management using electronic or manual systems.
• Lead as Change coordinator/Analyst with system houses.
• Review technical changes affecting processes and products.
• Advise on required documentation for changes.
• Drive improvement in change control and archival management.
• Support management review preparations and status tracking.
• Oversee CAPA process, root-cause analysis tools, and effectiveness targets.
• Maintain quality documentation and records archiving process.
• Distribute/retrieve controlled documents to users.
• Assist quality awareness training including new hire orientation.
• Contribute to QMS improvement initiatives and projects.

Skills

Quality management

Change control

Documentation

CAPA

Audits

Training delivery

Interdepartmental collaboration

MS Office proficiency

Education

Technical / scientific degree

Tools

Aras PLM

SAP

MES

LMS

SharePoint

Teams

PowerPoint

Job description

BIOTRONIK is seeking a QMS Engineer in Singapore to implement and maintain Quality Management Systems across change control, documentation/records, and training. You will interface with global system houses, plan audits, review validations and DHR/DMR, and drive QMS improvements.

The role emphasizes training delivery, KPI reporting, and cross-functional collaboration. You will contribute to harmonization of global processes, support CAPA activities, and ensure compliance with CGMP and medical