Quality Systems & Compliance 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

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.