Quality Inspector – Medical Device QC & ISO 13485

- HERAEUS MEDICAL COMPONENTS SINGAPORE PTE. LTD.; Singapore; On-site; SGD 42,000 - 66,000; Full time

Job description

About the role

The primary responsibility of this position is to perform product inspections, quality control testing, equipment calibration and verification, and quality record management. The role also supports the maintenance of ISO13485 Quality Management System, continuous improvement activities, and product failure investigations within a medical device contract manufacturing environment.

The position also ensures that products and processes meet applicable product specifications, internal procedures, customer requirements and ISO 13485 requirements.

Key responsibilities

Quality Management System:

• Prepare and maintain quality-related documents and records, such as Certificates of Analysis (CoA), inspection reports, quality records and traceability records
• Ensure documentation is accurate and complies with internal quality procedures, customer requirements, and ISO 13485 requirements
• Support internal and external audits by preparing records, demonstrating applicable processes, and providing inspection or testing data when requested
• Maintain a clean, safe, and audit-ready quality control work area

Equipment Calibration & Measurement System:

• Perform routine calibration and verification of measurement equipment/ tools in accordance with approved procedures.
• Maintain calibration records and ensure equipment/ tools remains in compliant state
• Identify and report equipment malfunction or deviations in a timely manner, and coordinate the necessary actions to restore the equipment to a compliant operating condition

Nonconformance and failure investigation support:

• Support product failure investigations by collecting evidence, performing re-tests as appropriate, and supporting root cause analysis
• Document nonconformances, participate in containment activities, and support CAPA implementation where required

Environmental Health and Safety (EHS) and Sustainability:

• Ensure QA activities comply with all applicable EHS regulations, standards, and company policies
• Act as a key backup for critical QA functions, ensuring seamless quality operations and mitigating risks associated with limited team size.

Other duties as assigned

What we're looking for

• Minimum 1 year of relevant working experience in Quality Control (QC), Quality Assurance (QA), or manufacturing operations.
• Basic understanding of ISO 13485 quality management system requirements.
• Experience in QC testing, analysis, and documentation, including preparation of test reports and maintenance of quality records.
• Proficient in Microsoft Office applications (Excel, Word, and PowerPoint) for data recording, reporting, and documentation. Experience with SAP is an added advantage.
• Good working knowledge of spoken and written English to understand work instructions, quality procedures, technical documentation, and accurately prepare inspection and test records.
• Knowledge of inspection, testing, and measurement systems. Hands-on experience with equipment such as Scanning Electron Microscope (SEM), Differential Scanning Calorimeter (DSC), tensile tester, OGP SmartScope, cross-sectional analysis equipment, and other metrology instruments is an advantage.
• Experience in operational quality activities, including incoming inspection, in-process inspection, final/outgoing inspection, cleanroom environmental monitoring, non-conformance management, and change control processes.
• Detail-oriented with strong analytical, problem-solving, and communication skills.
• Able to work independently as well as collaboratively in a team environment.
• Able to work night shifts