EMEA Quality & Compliance Lead – Service & Repair

360Pharma; Netherlands; On-site; EUR 75,000 - 110,000; Full time

Job summary

360Pharma in Amersfoort, Netherlands seeks a Quality & Compliance expert to lead quality programs for EMEA service centers and ensure ISO 13485 compliance across equipment validation and supplier management.

You will drive CAPA, change control, audits, and continuous improvement in a regulated medical devices environment, collaborating with global teams and travel as required. Fluent English is essential.

Qualifications

• Bachelor degree or equivalent in engineering, science or quality/compliance disciplines.
• At least 5 years of Quality experience in medical devices and validation of equipment preferred.
• Lean Six Sigma Green/Black Belt recommended; PM certification an asset.
• Experience in regulated ISO 13485 industries.
• Excellent communication and organizational skills.
• Ability to work under time pressure in global teams.
• Fluent in English and travel-ready if required.

Responsibilities

• Be the main contact for quality and compliance for EMEA Service Centers.
• Ensure general compliance support for QS procedures at all Service Centers.
• Lead validation of equipment and computer systems.
• Manage qualification and supplier oversight for Installation & Servicing.
• Collaborate with Service Operations to harmonize service processes.
• Support reporting, CAPAs, audits, and deviation investigations.
• Track monthly quality metrics and participate in reviews.
• Coordinate audits and internal/external requirements for the Netherlands Service Center.
• Contribute to updating global procedures and harmonization.
• Provide training on procedural changes and document deviations.
• Manage initiation and review of Service Level Agreements.
• Communicate business issues or opportunities to management.
• Conduct data-driven analysis and lead continuous improvement.
• Maintain awareness of ISO standards while solving business needs.

Skills

CAPA

QC

Quality Validation

English Fluent

Risk Based Decisions

Education

Bachelor degree in engineering/science/quality disciplines

Tools

ETQ

Windchill

MD S&R

Job description

360Pharma in Amersfoort, Netherlands seeks a Quality & Compliance expert to lead quality programs for EMEA service centers and ensure ISO 13485 compliance across equipment validation and supplier management.

You will drive CAPA, change control, audits, and continuous improvement in a regulated medical devices environment, collaborating with global teams and travel as required. Fluent English is essential.