Validation & Qualification Engineer
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.