Experienced Validation & Quality Engineer

Location: Waalre & HTC Eindhoven
Contract: 32–40 hours/week (0.8–1.0 FTE)
Position: Quality Engineer
Department: Quality
Contact: HR – jobs@vivolta.com – +31 (0)40 282 7956

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.

QMS
– 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.
– Manageand 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, Knowledge & Skills
– Minimum 3 years of experience in a Quality Engineering or Validation role (must).
– Experience in the medical devices industry (must).
– 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 Bel