Quality Systems Specialist – Medical Device

About the role

Our client, Trelleborg Medical Solutions, seeks a Quality Systems Specialist to support manufacturing processes within a regulated medical-device environment. The role focuses on maintaining the Quality Management System (QMS) to ensure compliance with regulatory, quality, and company requirements.

Key responsibilities

• Plan, conduct and report internal audits; support ISO notified body, customer and FDA inspections.
• Maintain audit schedules, audit documentation and coordinate external audit activities.
• Develop metrics, perform trend analysis on audit findings, CAPAs, non-conformances and present improvements to management.
• Own CAPA investigations, drive corrective and preventive actions and ensure timely closure.
• Manage controlled document lifecycle, including reviews, approvals and compliance with ISO/FDA standards.
• Support non-conforming material, complaint handling, deviations, RMA and related processes.
• Provide quality-system training and lead projects to enhance the QMS.

Required profile

• Engineering degree.
• 3+ years of quality/regulatory experience in the medical-device sector.
• Strong knowledge of GMP, ISO 9001, ISO 13485 and FDA 21 CFR 820.
• Proficiency in English (B2+).

Required skills

• GMP compliance.
• ISO 9001 and ISO 13485 standards.
• FDA 21 CFR 820 requirements.
• Internal and external audit execution.
• CAPA management and root-cause analysis.
• Document control and lifecycle management.
• Metric development and trend analysis.