Precision Cleanroom Operator – Medical Devices (GMP/ISO 13485)

Xeltis; Eindhoven; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Competitive salary

Permanent position

New facility

Career progression

25 vacation days

Pension scheme

Travel allowance

International team

Job summary

Xeltis is scaling up commercial manufacturing of its CE-marked vascular implants. You will join a newly built ISO Class 7 cleanroom at High Tech Campus Eindhoven, working to GMP and ISO 13485 standards in a growing production team.

As a Cleanroom Operator you will manufacture vascular implants, perform precision assembly, document batch records, and support quality control. The role offers a permanent position in a fast-growing MedTech company with clear career progression and international

Qualifications

• Regulated manufacturing experience in medical devices, pharmaceuticals, biotech or GMP ISO 13485 environments.
• Hands-on production documentation, batch records and deviation management.
• Excellent manual dexterity and meticulous attention to detail.
• Strong sense of ownership and ability to flag quality concerns early.
• Good communication skills in English; production language.

Responsibilities

• Manufacture vascular implants in an ISO Class 7 cleanroom environment.
• Perform precision manual assembly and operate production equipment per procedures.
• Execute IPCs and document manufacturing activities accurately.
• Maintain audit-ready batch records and production documentation.
• Collaborate with Quality Control and Quality Assurance on inspections and release.
• Identify opportunities to improve process quality and efficiency as volumes grow.
• Assist onboarding and training of new colleagues as you progress toward senior roles.

Skills

Manual dexterity

Attention to detail

Ownership

English proficiency

Education

MBO Level 4 qualification (or equivalent)

Job description

Xeltis is scaling up commercial manufacturing of its CE-marked vascular implants. You will join a newly built ISO Class 7 cleanroom at High Tech Campus Eindhoven, working to GMP and ISO 13485 standards in a growing production team.

As a Cleanroom Operator you will manufacture vascular implants, perform precision assembly, document batch records, and support quality control. The role offers a permanent position in a fast-growing MedTech company with clear career progression and international