Quality Assurance Specialist

Smith group; Haarlem; Hybrid; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Smith group in Haarlem is seeking a Quality Assurance Specialist to support the Quality Management System and ensure ongoing compliance with ISO standards. You will work across QA disciplines to maintain documentation, support audits, and drive CAPA actions.

You will analyze quality data, participate in audits, coordinate corrective actions, and assist calibration and supplier quality activities to strengthen overall quality performance.

Qualifications

• Experience maintaining QMS (ISO 9001, ISO 13485, ISO 14001) and ensuring compliance.
• Knowledge of internal and external audits, CAPA, and quality records.
• Ability to analyze quality data and identify trends.
• Support calibration and supplier-related quality activities.

Responsibilities

• Maintain and update the QMS and quality documentation.
• Participate in internal audits and support external audits.
• Investigate non-conformities and coordinate CAPA actions.
• Assist in process controls and data analysis for future improvements.
• Maintain calibration records and inspection/testing equipment standards.

Job description

## Quality Assurance SpecialistApply: Haarlem, The Netherlands: Full time: Posted 30+ Days Ago: REQ-2046## Quality Systems & Compliance• Maintain and support the organization’s Quality Management System (QMS) in accordance with applicable standards (e.g., ISO 9001, ISO 13485, ISO 14001,etc).• Ensure quality policies, procedures, and work instructions remain up to date and compliant.• Prepare and maintain quality documentation, logs, reports, and audit records.## Audit Support & Execution• Participate in internal audits and support external audits with certification bodies, customers, or regulatory authorities.• Assist in audit preparation activities, evidence gathering, and follow-up actions.• Monitor audit findings and coordinate corrective and preventive action activities (CAPA).## Corrective & Preventive Action (CAPA) Management• Investigate quality issues and non-conformities to determine root cause.• Develop and track corrective and preventive action plans to ensure timely closure.• Verify the effectiveness of implemented actions.## Process & Quality Control• Support process owners in maintaining consistent quality controls across workflows.• Review and analyze quality data to identify trends or improvement opportunities.• Conduct quality inspections, sampling, or verification activities as required.## Continuous Improvement•Assist the Process Automation Specialist with identifying opportunities to optimize processes, reduce defects, and strengthen compliance.• Collaborate with cross-functional teams to drive quality improvements.## Supplier & Calibration Support• Maintain calibration records and ensure equipment used for inspection and testing is up to standard.*We are an Equal Opportunity/Affirmative Action Employer.*