Regulated QC Specialist | Process & Quality Improvement

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 48,000 - 72,000; Full time

Job summary

Recruit Express PTE LTD is seeking a QC Specialist I to drive quality control in a regulated manufacturing environment. You will resolve product quality issues with Production, Manufacturing Engineering and Supplier Quality, while monitoring data, supporting QC labs and ensuring compliance with ISO 13485 and MDSAP.

Key responsibilities include leading non-conformances, monitoring yields, assisting in failure analyses, and maintaining QC criteria and training for technicians.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Life Sciences or a related discipline.
• At least 3 years of experience in manufacturing quality control in a regulated environment.
• 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 GLP and handling/disposal of biohazard materials.
• Experience with ERP systems; 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.

Responsibilities

• Lead and coordinate review of internal and supplier non-conformances with timely investigation, disposition and closure.
• Monitor QC test yields and collaborate with Engineering and Manufacturing to improve processes and QC procedures.
• Participate in customer complaint reviews and support failure analysis of returned instruments.
• Establish and maintain Quality Control criteria; provide training to QC Technicians.
• Monitor quality trends and implement improvements to achieve KPIs.
• Manage day-to-day QC laboratory activities to support production and maintain equipment; troubleshoot as needed.
• Identify opportunities to improve QC laboratory practices and processes.
• Participate in Process Validation activities to ensure proper QC measures are in place.
• Prepare weekly and monthly quality performance reports for Management Review.

Skills

Statistical analysis

Quality problem solving

Leadership

Independent worker

Education

Bachelor's degree in Chemistry/ Biochemistry/ Life Sciences

Tools

SAP

ERP systems

Job description

Recruit Express PTE LTD is seeking a QC Specialist I to drive quality control in a regulated manufacturing environment. You will resolve product quality issues with Production, Manufacturing Engineering and Supplier Quality, while monitoring data, supporting QC labs and ensuring compliance with ISO 13485 and MDSAP.

Key responsibilities include leading non-conformances, monitoring yields, assisting in failure analyses, and maintaining QC criteria and training for technicians.