Job Description

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:
[Confidential Information]

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

Consultant: Ashley Loo
Designation: Senior Recruiter
CEI Reg No: R2095115
Recruit Express Pte Ltd Company Reg. No. 199601303W | EA License Number: 99C4599