QC Specialist (Contract, Medical MNC) #HYN

About the Role

We are looking for a QC Specialist I to support quality control activities within a regulated manufacturing environment. You will be responsible for driving the resolution of product quality issues while working closely with Production, Manufacturing Engineering and Supplier Quality teams.

The role will also involve monitoring process and QC data, identifying improvement opportunities, supporting QC laboratory activities, and ensuring processes comply with ISO 13485, MDSAP and applicable regulatory requirements.

Key Responsibilities

• Lead and coordinate the review of internal and supplier non-conformances, ensuring timely investigation, disposition and closure of quality notifications.
• Monitor QC test yields and collaborate with Engineering and Manufacturing teams to identify and implement improvements to manufacturing processes and QC procedures.
• Participate in customer complaint reviews and support failure analysis of returned instruments to verify complaints and identify product quality improvement opportunities.
• Establish and maintain Quality Control criteria, providing training and guidance to QC Technicians where required.
• Monitor process and product quality trends and implement improvement initiatives to achieve quality and operational KPIs.
• Manage day-to-day QC laboratory activities to support production requirements, including maintaining laboratory equipment and troubleshooting issues where necessary.
• Identify and implement opportunities to improve QC laboratory practices and processes.
• Participate in and review Process Validation activities to ensure appropriate Quality Control measures are in place.
• Prepare weekly and monthly quality performance reports for trend analysis and presentation during Management Review meetings.
• Support QC instrument testing, reagent management and procedural updates to ensure quality standards and delivery commitments are met.

Requirements

• Bachelor’s Degree in Chemistry, Biochemistry, Life Sciences or a related discipline.
• At least 3 years of experience in manufacturing quality control, preferably within a regulated environment with exposure to QC laboratory operations.
• Experience in Process Validation, Non-Conformance Management and Customer Complaint Investigation.
• Knowledge of ISO 13485 and/or MDSAP requirements is preferred.
• Lead Auditor certification would be an advantage.
• Knowledge of Good Laboratory Practice (GLP) and experience handling and disposing of biohazard materials.
• Experience with ERP systems is advantageous; SAP knowledge is preferred.
• Hands-on experience applying statistical tools for quality analysis.
• Lean Six Sigma Green Belt certification would be an advantage.
• Strong problem-solving, communication, interpersonal and leadership skills.
• Self-motivated, results-oriented and able to work independently with minimal supervision.

Why Join?

This is a great opportunity for a QC professional to gain hands-on experience in a regulated manufacturing environment, working across Quality, Engineering, Manufacturing and Supplier Quality functions while contributing to continuous improvement initiatives.

📩 Interested candidates, please send your updated CV to [email protected]
We regret to inform that only shortlisted candidates will be notified.

Ashley Loo Yan Ni | R2095115 | EA License Number: 99C4599

Recruit Express Pte Ltd Company Reg. No.199601303W