Validation & Qualification Engineer

Experts Group International; Pforzheim; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Career development

Long-term stability

Cross-functional collaboration

Zusammenfassung

Experts Group International, on behalf of a leading medtech manufacturer, seeks a Validation & Qualification Engineer to plan, execute, and document process validations and equipment qualifications under ISO 13485.

You will work hands-on with production, engineering, and quality assurance, ensure ongoing regulatory compliance, support audits, and drive validation process improvements across IQ/OQ/PQ activities. Fluent German and English are expected, along with a structured, analytical approach.

Qualifikationen

• Completed studies in engineering or medical technology 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 and machine/system qualifications (IQ/OQ/PQ).
• Familiarity with CAPA, complaint, and change management processes.

Aufgaben

• 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.

Kenntnisse

ISO 13485

Process Validation

Qualification Planning

CAPA & Change Mgmt

Regulatory Compliance

Risk Analysis

Documentation

Ausbildung

Engineering Degree

Medical Technology

Quality Management Training

Tools

IQ/OQ/PQ

QMS Tools

Jobbeschreibung

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.