Clean Room QC Technician — Incoming Quality (cGMP)

BIOTRONIK APM II PTE. LTD.; Singapore; On-site; SGD 42,000 - 60,000; Full time

Benefits offered by this job

Entrepreneurial mindset encouraged

Global teams and projects

Professional development

Job summary

BIOTRONIK APM II PTE. LTD. is seeking a Quality Control Inspector/Technician to oversee and execute quality operations in a clean room environment.

You will ensure incoming inspections comply with BIOTRONIK specifications under cGMP and quality systems. The role involves data analysis, non-conformity handling, and documentation in QM systems. The ideal candidate has 2+ years in quality roles, familiarity with CMM/vision measuring equipment, and proficiency in SAP or MES.

Qualifications

• Formal engineering education or equivalent.
• Experience in quality technician role in regulated manufacturing is a plus.

Responsibilities

• Oversee incoming inspection operations according to cGMP and QM requirements.
• Perform inspections against procedures, work instructions, drawings or specifications.
• Disposition of non-conformities and block products for investigation as needed.
• Conduct mechanical, visual, functional inspections on materials and assemblies to meet specs.
• Support First Article/First Piece approvals and prioritize inspections per schedule.
• Label, inventory, and record inspection data and defective storage locations.
• Generate detailed inspection records and non-conformance reports.
• Train and certify staff on inspection specifications.
• Monitor QM compliance and verify issues in production areas.
• Manage inspection records and archiving of documents.
• Assist projects and other tasks as directed by engineers or supervisor.

Skills

Quality inspection techniques

Measuring instruments handling

Reading technical drawings

Education

GCE O' Level / NITEC in mechanical, mechatronic or related engineering

Tools

SAP

MES

CMM

Smart Scope

Vision measuring system

Microsoft Office (Outlook, Word, Excel, PowerPoint, SharePoint, Teams)

Job description

BIOTRONIK APM II PTE. LTD. is seeking a Quality Control Inspector/Technician to oversee and execute quality operations in a clean room environment.

You will ensure incoming inspections comply with BIOTRONIK specifications under cGMP and quality systems. The role involves data analysis, non-conformity handling, and documentation in QM systems. The ideal candidate has 2+ years in quality roles, familiarity with CMM/vision measuring equipment, and proficiency in SAP or MES.