Experienced Validation & Quality Engineer

Vivolta; Eindhoven; Hybrid; EUR 65,000 - 85,000; Full time

Benefits offered by this job

Pension

25+ days off

5 ADV days

Lease-a-bike

Job summary

Vivolta in the Netherlands is seeking a hands-on Quality Engineer to strengthen the Quality team in a regulated CDMO environment. You will lead validation activities, develop test methods, and support SPC and process validation in collaboration with Manufacturing, Engineering and R&D.

The role emphasizes ISO 13485:2016, FDA and EU MDR compliance, QMS maintenance, internal and external audits, CAPA, risk management, and documentation discipline.

Qualifications

• Bachelor’s degree in a technical discipline (see Education).
• Minimum 3 years in Quality Engineering or Validation in medical devices (must).
• Strong knowledge of ISO 13485, ISO14644 and QMS documentation structures.
• Experience with FDA and EU MDR regulatory requirements.

Responsibilities

• Plan, execute, review, and document validation activities for equipment, utilities, cleanroom processes, manufacturing processes, software/tools where applicable, and test methods.
• Support quality management system improvements and maintenance (CAPA, change control, supplier quality).
• Prepare and perform internal audits and support external audits (Notified Body, customers, regulators).
• Conduct risk management activities (FMEA) and root-cause analyses; implement corrective actions.

Skills

Analytical & problem-solving

Fluent English

Education

Bachelor’s degree in Chemical Engineering, Chemistry, Biomedical Engineering, Biology, Medical Biology, Laboratory Research, or related technical discipline

Tools

Statistical tools

Six Sigma Green Belt

Job description

Location: Waalre & HTC Eindhoven

Contract: 32–40 hours/week (0.8–1.0 FTE)

Position: Quality Engineer

Department: Quality

Contact: HR - [e-mail] - [phone]

About Vivolta

Vivolta is a fast-growing MedTech company specializing in the contract development and manufacturing of electrospun medical implants. Vivolta is as Contract Development and Manufacturing Organization (CDMO) active in the medical device industry. Our manufacturing takes place in a validated cleanroom environment. We support our customers from development through industrialization and manufacturing, operating within a highly regulated environment where quality, compliance, and reliability are central to everything we do.

The role

To strengthen our Quality team, we are looking for a hands-on quality engineer with a strong focus on validation, statistics and Quality Management Systems. As a Quality Engineer, you are part of the Quality Department and report directly to the Quality Manager. You work closely with the Manufacturing, Engineering and R&D departments within our regulated CDMO environment.

What will you do as Quality Engineer?

Validation

• Plan, execute, review, and document validation activities for equipment, utilities, cleanroom processes, manufacturing processes, software/tools where applicable, and test methods.
• Ensure validation activities are risk‑based and aligned with intended use, customer requirements, and regulatory expectations.
• Support equipment releases and process validation activities.
• Perform product and process validation and implement Statistical Process Control (SPC).
• Develop and validate test methods for customer projects in line with regulatory requirements.
• Ensure validation documentation is complete, traceable, and audit-ready.

Quality Management System

• The Quality Engineer supports the Quality Manager in maintaining and improving Vivolta’s QMS and takes ownership of assigned validation, audit, CAPA, change control, and supplier quality activities.
• Support maintenance and continuous improvement of the QMS in accordance with ISO 13485:2016.
• Ensure compliance with applicable regulatory requirements (FDA, EU MDR, and where applicable GMP).
• Support maintenance of technical documentation, validation files, device history documentation, and customer/project quality documentation where applicable.
• Contribute to management reviews and quality reporting.
• Train colleagues on QMS procedures and system updates to ensure organization‑wide compliance.

Auditing

• Prepare and perform internal audits.
• Support external audits (Notified Body, customer, regulatory authority).
• Assist in supplier audits, supplier selection, and supplier performance monitoring.

Risk & Compliance

• Manage and support NCR, SCAR, CAPA, and Change Request processes.
• Execute risk management activities (e.g., FMEA).
• Conduct root cause analyses and ensure effective corrective and preventive actions.
• Investigate customer complaints and assess product failure risks.

What do we hope you will bring to the table?

You thrive in an innovative and team-oriented environment, where you can spar with colleagues, exchange ideas, and grow together.

Education

• Bachelor’s degree (HBO) or higher in Chemical Engineering, Chemistry, Biomedical Engineering, Biology, Medical Biology, Laboratory Research, or a related technical discipline.

Experience

• Minimum 3 years of experience in a Quality Engineering or Validation role (must).
• Experience in the medical devices industry (must).

Knowledge & Skills

• Strong knowledge of ISO 13485, ISO14644 and QMS documentation structures.
• Knowledge of medical device regulations (FDA and EU MDR).
• Proven experience drafting validation protocols and technical reports.
• Strong analytical and problem-solving skills.
• Experience with statistical tools and methods; a background in Lean or Six Sigma (e.g. Green Belt level) is a strong advantage.
• Structured and documentation-driven working style.
• High attention to detail and regulatory awareness.
• Proactive mindset and strong communication skills.
• Fluent in English (written and spoken).
• Comfortable working in a collaborative, multidisciplinary team environment.

Why Vivolta?

We offer a challenging and responsible position within a unique growing and quality-driven organization. You will have the opportunity to contribute directly to regulatory compliance, validation excellence, and continuous improvement in a dynamic CDMO environment. You will join a professional team where collaboration, ownership and quality are key.

We offer:

• Excellent secondary benefits, such as pension, 25+ days off and 5 ADV days and a company lease-a-bike option.
• Development opportunities through training and/or courses, both in‑house and external.
• A professional yet fun workplace with passionate colleaguesandinnovativeequipment.
• Team-building activities that support both professional growth and workplace enjoyment.
• Unique perks such as Stock Appreciation Rights (SARs) upon transition to a permanent contract.
• A long‑term career perspective within a fast‑growing company.

Questions?

Feel free to contact us at [e-mail] or call [phone].

Please note:

We are building our team directly and are not engaging with external recruitment agencies at this time.

Also,

Vivolta is not a recognized sponsor for visa applications. This means we’re currently only able to consider candidates with a valid EU work permit.