Quality Control Specialist I

About the role

We are looking for a Quality Control Specialist I to lead the resolution of product quality issues by working closely with production, manufacturing engineering and supplier quality teams. The role ensures compliance with ISO 13485, MDSAP and other regulatory requirements while supporting QC instrument testing and reagent management.

Key responsibilities

• Initiate and lead internal and supplier non‑conformance review meetings to ensure timely disposition of quality notifications.
• Monitor QC test yield and collaborate with engineering and manufacturing to implement process and test improvements.
• Participate in complaint review meetings and conduct failure analysis of returned instruments.
• Establish QC criteria, train technicians and maintain a validated laboratory, including equipment troubleshooting.
• Support site process validation activities and generate weekly/monthly quality performance reports for management review.
• Identify and drive improvement initiatives to meet KPI targets and regulatory standards.

Required profile

• Bachelor’s degree in Chemistry, Biochemistry or a related life‑science field.
• Minimum 3 years of manufacturing quality control experience in a regulated environment.
• Experience with process validation, non‑conforming processes and customer complaint investigations.
• Knowledge of ISO 13485, MDSAP and Good Laboratory Practice (GLP); lead auditor certification preferred.
• Self‑motivated, result‑oriented with strong problem‑solving and communication skills.

Required skills

• Process Validation
• Non‑conforming Process Management
• Customer Complaint Investigation
• ERP systems (SAP preferred)
• ISO 13485 and MDSAP compliance
• Good Laboratory Practice (GLP)
• Statistical analysis tools
• Lean Six Sigma Green Belt