Cleanroom Operator Medical Devices

ASQ Recruitment; Eindhoven; On-site; EUR 31,000 - 40,000; Full time

Benefits offered by this job

Travel allowance

Brand-new production facility

International team

Job summary

ASQ Recruitment is hiring a Cleanroom Operator in Eindhoven to manufacture vascular implants in a brand-new ISO Class 7 facility, ensuring GMP/ISO 13485 compliance. You will perform precise manual assembly, operate production equipment, and document activities while maintaining audit-ready batch records.

The role offers growth into senior production positions within a rapidly expanding medtech company, with a travel allowance and an international, hands-on team.

Qualifications

• Minimum 2 years in a regulated manufacturing environment (medical devices or GMP/ISO13485).
• Hands-on experience with production documentation and batch records.
• Excellent manual dexterity and meticulous attention to detail.
• Strong ownership mindset with ability to raise quality concerns.

Responsibilities

• Manufacture vascular implants in ISO Class 7 cleanroom.
• Operate production equipment per approved procedures.
• Perform IPC and document manufacturing activities.
• Maintain audit-ready batch records.
• Collaborate with QC/QA on inspections and release.
• Identify opportunities to improve process, quality and efficiency as volumes grow.
• Support onboarding and training of new colleagues as you grow into a more senior role.

Skills

Manual dexterity

Attention to detail

Ownership mindset

English communication

Regulated manufacturing experience

Documentation

Tools

Production equipment operation

Job description

Ready to build medical devices that keep patients alive? A fast-growing medtech company in Eindhoven is scaling up commercial production of its CE-marked vascular implants, and is looking for an experienced Cleanroom Operator to help make it happen. You will manufacture life-saving implants in a brand-new ISO Class 7 cleanroom, working to GMP and ISO 13485 standards. This is not a seat on an established line. You will help shape how a new facility runs from day one. If precision, ownership and real impact matter to you, keep reading.

About the role

As a Cleanroom Operator, you manufacture high-quality medical devices while ensuring full compliance with GMP and quality standards. Your responsibilities include:

• Manufacturing vascular implants in an ISO Class 7 cleanroom environment
• Performing precision manual assembly and operating production equipment according to approved procedures
• Executing in-process controls (IPC) and accurately documenting manufacturing activities
• Maintaining complete, audit-ready batch records and production documentation
• Working closely with Quality Control and Quality Assurance on inspections and product release
• Spotting opportunities to improve process, quality and efficiency as production volumes increase
• Supporting the onboarding and training of new colleagues as you grow into a more senior role

Qualifications

• At least 2 years of experience in a regulated manufacturing environment, for example: medical devices, pharmaceuticals, biotechnology, GMP-regulated production, or ISO 13485 environments
• Hands-on experience with production documentation, batch records and deviation management
• Excellent manual dexterity and attention to detail that never switches off
• A strong sense of ownership: you flag and elevate quality concerns before they become deviations
• Good communication skills and working proficiency in English
• A plus: experience in commercial medical device manufacturing, producing implants, grafts, stents or other implantable products, and/or product inspection or quality control experience

Offer

• Salary between €2,800 and €3,600 gross per month, based on experience
• Full-time position, 40 hours per week
• Working within a rapidly growing MedTech company with a CE-marked product and a clear commercial roadmap
• A brand-new, state-of-the-art production facility at High Tech Campus Eindhoven
• Clear career progression into a more senior production role
• Travel allowance
• An international, hands-on team where craftsmanship is genuinely valued

About the company

This is a leading medical technology company developing restorative vascular implants, based on Nobel Prize-winning supramolecular chemistry. Its devices enable the body to regenerate living tissue and restore natural function. With CE marking achieved for its flagship vascular access graft, the company is entering an exciting phase of commercial growth, manufacturing life-changing products right in Eindhoven for patients who depend on them every day.