Quality Assurance Specialist

Smith & Associates; Amsterdam; On-site; EUR 55,000 - 85,000; Full time

Job summary

Smith & Associates seeks a Quality Systems & Compliance professional to maintain the organization’s QMS in accordance with ISO standards and to ensure policies and procedures remain compliant. You will prepare documentation, logs, and audit records and support audit activities.

You will participate in audits, gather evidence, and track CAPA actions while driving continuous process improvements and calibration support across functions.

Qualifications

• Maintain the organization’s QMS in line with applicable standards (e.g., ISO 9001, ISO 13485, ISO 14001).
• Ensure quality policies, procedures and work instructions stay current and compliant.
• Prepare and maintain quality documentation, logs, reports, and audit records.

Responsibilities

• 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 CAPA activities.

Skills

Quality Management

Audits

CAPA

Data Analysis

Process Improvement

Job description

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.