QC Specialist (Medical) #HYN

Job Overview

We are seeking a Quality Control Specialist to support product quality, manufacturing process improvement and laboratory operations within a regulated manufacturing environment. This role works closely with cross-functional teams to investigate quality issues, drive corrective actions and ensure compliance with applicable quality standards and regulatory requirements.

Job Responsibilities

• Coordinate internal and supplier non-conformance reviews to ensure timely investigation, resolution and closure of quality notifications.

• Monitor QC testing yields and collaborate with Manufacturing and Engineering teams to identify and implement process improvements.

• Participate in customer complaint reviews and failure analysis of returned instruments to identify root causes and opportunities for product quality improvement.

• Establish quality control criteria and provide guidance and training to QC Technicians.

• Monitor process performance, product quality and quality trends, implementing improvement initiatives to achieve quality objectives.

• Oversee QC laboratory activities to support manufacturing operations and maintain a validated laboratory environment.

• Troubleshoot laboratory equipment issues and identify opportunities to improve laboratory efficiency and practices.

• Participate in process validation activities and review validation outcomes to ensure adequate quality controls.

• Prepare weekly and monthly quality performance reports, conduct trend analysis and present findings during management reviews.

• Support reagent management, QC instrument testing and procedural updates to ensure operational and delivery requirements are met.

• Ensure compliance with relevant quality management systems, regulatory requirements and laboratory practices.

• Work with internal stakeholders and suppliers to drive effective corrective and preventive actions.

Job Requirements

• Bachelor's degree in Chemistry, Biochemistry, Life Sciences or a related discipline.

• At least 3 years of manufacturing Quality Control experience, preferably within a regulated industry and with exposure to QC laboratory operations.

• Experience in process validation, non-conformance management and customer complaint investigations.

• Familiarity with ISO 13485, MDSAP requirements and Good Laboratory Practice (GLP).

• Knowledge of laboratory safety procedures, including the handling and disposal of biohazardous materials.

• Experience with ERP systems; SAP knowledge would be advantageous.

• Hands-on experience with statistical tools and quality improvement methodologies; Lean or Six Sigma Green Belt certification would be an advantage.

• Lead Auditor certification would be an added advantage.

• Strong analytical, problem-solving, communication and interpersonal skills, with the ability to work independently and collaborate effectively across teams.

Interested applicants, please email your detailed CV to:
[email protected]

All information will be treated with confidentiality and we regret that only selected candidates will be notified

Consultant: Ashley Loo
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