Drive Quality. Strengthen Processes. Make an Impact.
Are you a quality professional with experience in regulated manufacturing and QC laboratory environments
Join a dynamic production environment where you'll play a key role in resolving product quality issues, improving manufacturing processes, supporting regulatory compliance, and driving continuous improvement initiatives.
As a QC Specialist, you'll work closely with Production, Manufacturing Engineering, Supplier Quality, and other cross-functional teams to ensure products consistently meet quality and regulatory expectations.
What You'll Be Doing
- Lead and coordinate the review and resolution of internal and supplier non-conformances, ensuring timely disposition and closure.
- Monitor QC testing yields and process performance to identify trends, quality gaps, and opportunities for improvement.
- Partner with Engineering and Manufacturing teams to implement improvements to production processes and QC test procedures.
- Participate in customer complaint reviews and support failure analysis of returned instruments to identify potential product quality improvements.
- Establish appropriate process quality control criteria and provide guidance and training to QC Technicians where required.
- Monitor product and process quality trends and drive improvement initiatives aligned with organisational quality objectives and KPIs.
- Oversee QC laboratory activities supporting production and maintain laboratory readiness, including troubleshooting of equipment when required.
- Identify and implement opportunities to improve QC laboratory practices, processes, and efficiency.
- Participate in process validation activities and review validation outcomes to ensure appropriate quality controls are established.
- Prepare weekly and monthly quality performance reports for trend analysis and management review.
- Support compliance with ISO 13485, MDSAP, and applicable regulatory requirements.
- Apply data-driven problem-solving and statistical analysis to support quality and process improvement initiatives.
What We're Looking For
- 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 environment with exposure to QC laboratory processes.
- Experience in process validation, non-conformance management, and customer complaint investigation.
- Familiarity with ERP systems SAP experience will be advantageous.
- Knowledge of ISO 13485 and/or MDSAP requirements Lead Auditor certification will be an advantage.
- Working knowledge of Good Laboratory Practice (GLP) and appropriate handling and disposal of biohazard materials.
- Hands-on experience applying statistical tools for quality and process analysis.
- Lean Six Sigma Green Belt certification or experience will be an advantage.
- Strong analytical, problem-solving, communication, interpersonal, and leadership capabilities.
- Self-motivated, results-oriented, and able to work independently while collaborating effectively with cross-functional teams.
Why Consider This Opportunity
Take on a role that goes beyond routine quality inspection. You'll have the opportunity to influence product quality, manufacturing processes, laboratory practices, regulatory compliance, and continuous improvement while working closely with multiple technical teams.
If you have experience in regulated manufacturing, medical technology, biotechnology, life sciences, or a related quality environment, we'd be keen to hear from you.
Interested candidates are invited to submit an updated CV.
Email: [Confidential Information]
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd
EA License No. 99C4599
