Auf einen Blick
- Aufgaben: Plane und dokumentiere Prozessvalidierungen und Qualifikationen in einem dynamischen Medtech-Umfeld.
- Unternehmen: Führender Hersteller von hochpräzisen medizinischen Geräten mit Fokus auf Qualität und Zuverlässigkeit.
- Vorteile: Wettbewerbsfähige Vergütung, langfristige Karriereentwicklung und direkte Zusammenarbeit mit Führungskräften.
- Weitere Informationen: Hochwertige Arbeitsumgebung mit Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung.
- Warum dieser Job: Gestalte die Zukunft der Medizintechnik und arbeite an compliance-kritischen Projekten.
- Qualifikationen: Mindestens 4 Jahre Erfahrung in der Prozessvalidierung und gute Kenntnisse der ISO 13485.
Das prognostizierte Gehalt liegt zwischen 50850 - 62150 € pro Jahr.
About the Role Our client is a leading manufacturer of high-precision medical devices and components, serving customers across the medtech industry with a strong focus on quality, reliability, and continuous improvement.
On their behalf, we are looking for an experienced Validation & Qualification Engineer to plan, execute, and document process validations and equipment qualifications — ensuring manufacturing operations remain fully compliant with ISO 13485 and applicable regulatory requirements.
This is a hands-on, high-impact role at the intersection of quality, engineering, and compliance within a growing, purpose-driven medtech business.
Your Responsibilities Plan, implement, and document process validations and qualifications in line with regulatory requirements and internal specifications.
Plan and participate in machine and plant qualifications (IQ/OQ/PQ).
Create, review, and maintain validation plans, risk analyses, test protocols, and validation reports.
Ensure ongoing compliance with ISO 13485 and relevant regulatory requirements.
Evaluate proposed changes in change management for their impact on existing validations.
Support deviations, complaints, and CAPA measures related to validation activities.
Drive the further development of validation processes and quality-relevant procedures.
Collaborate closely with production, engineering, quality assurance, and external service providers.
Support and accompany internal, external, customer, and authority audits.
What You Bring Completed studies in engineering, medical technology, natural sciences, or a comparable technical education with corresponding further training.
At least 4 years of professional experience in process validation and/or qualification within a regulated environment.
In-depth practical experience with quality management systems according to ISO 13485.
Experience planning, implementing, and documenting process validations as well as machine and system qualifications (IQ/OQ/PQ).
Familiarity with QMS processes such as CAPA, complaint, and change management.
Good knowledge of the relevant regulatory requirements in the medical device or pharmaceutical environment.
Confident handling of risk analyses and technical documentation.
Very good German and good English, both written and spoken.
A structured, analytical, and independent way of working.
What They Offer A hands-on, high-impact role at the intersection of quality, engineering, and compliance in a growing medtech business.
Competitive compensation in line with experience.
A stable, purpose-driven industry with long-term career development opportunities.
Direct collaboration with production, engineering, and quality assurance leadership on compliance-critical projects.
Validation & Qualification Engineer in Pforzheim Arbeitgeber: Experts Group International
Als Arbeitgeber bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf Teamarbeit und persönliche Entwicklung setzt. Unsere Unternehmenskultur fördert Transparenz und Leistung, während wir Ihnen durch gezielte Schulungen und Weiterbildungsangebote helfen, Ihre Karriere als Production Controller voranzutreiben. Zudem profitieren Sie von einer attraktiven Vergütung und flexiblen Arbeitszeiten, die es Ihnen ermöglichen, Beruf und Privatleben optimal zu vereinbaren.
Kontaktdaten:
Experts Group International Recruiting-Team
