Quality Control Specialist – ISO 13485/9001

About the role

The Quality Control Specialist will support the development and continuous improvement of the Quality Management System to maintain ISO 13485 and ISO 9001 certification. This role performs all QC functions, works closely with the Quality Assurance team, and requires hands‑on experience with LCMS and other analytical equipment.

Key responsibilities

• Drive implementation of new processes and perform routine QC activities.
• Conduct raw material, intermediate, in‑process, and final release analyses in accordance with GMP.
• Manage QC sample retention and qualification/routine operation of LCMS and other analytical instruments.
• Ensure compliance with ASTM/ISO standard test methods.
• Review and verify laboratory data, validation protocols, and reports.
• Investigate out‑of‑specification results using structured problem‑solving and root‑cause analysis, and implement corrective and preventive actions.
• Support continuous improvement of the QMS, customer projects, and quality performance initiatives.
• Maintain and update quality system documentation as needed.
• Assist QA activities such as NCR, CAPA, LIRs, change controls, and supplier qualification.
• Participate in audit preparation and liaise with suppliers on QC matters.
• Perform all tasks in compliance with company policies and support key projects as assigned.

Required profile

• 3rd‑level degree in science, engineering or medical field.
• Strong planning, organizational and communication skills.
• Detail‑oriented, hardworking and highly motivated.
• Proficient computer skills.
• Ability to work independently and as part of a team in a dynamic environment.

Required skills

• LCMS operation and maintenance.
• Other analytical instrumentation.
• GMP compliance.
• ISO 13485 and ISO 9001 knowledge.
• ASTM/ISO standard test methods.
• Data review and verification.
• Root‑cause analysis and CAPA.
• Audit preparation.