Hybrid Quality Engineer, SSU Instruments

at KARL STORZ

• Job title: Quality Engineer, SSU Instruments
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Tuttlingen, Germany

About the role

• Quality Engineer focused on optimizing documentation and compliance in the product lifecycle at medical device company. Collaborating with teams for audit preparation and regulatory adherence.

Responsibilities

• Define information structures: Continuously optimize information structures, documentation processes, and templates within the PLM ecosystem to ensure regulatory compliance and operational efficiency across the entire product lifecycle.
• Ensure completeness of the DHF/DMR: Maintain a complete, accurate, and compliant Design History File (DHF) and Device Master Record (DMR). Own the Project Data Plan and Phase Gate checklists in accordance with global regulatory standards and internal quality objectives.
• Create a structured filing system: Develop and maintain a lean, transparent, and comparable project structure for all projects and promptly report missing or time-critical DHF/DMR elements to the project manager.
• Develop strategies for legacy products: Provide guidance for updating technical documentation for existing products to efficiently ensure compliance.
• Prepare and conduct audits: Ensure that all project-relevant documents and evidence (e.g., DHF, DMR, development documentation, test reports) are complete, current, and audit-ready. Serve as the primary contact for auditors, coordinate audit preparation, and represent development projects during audits.
• Ensure design traceability: Ensure that issues from predecessor and similar products are considered in new product versions and that safety and quality aspects are incorporated into a clear requirements management system.
• Requirement assurance: Possess deep knowledge of regulatory and product-specific requirements for sterile single-use products and ensure their safe, compliant, and reproducible quality.

Requirements

• Degree in a natural science or engineering discipline.
• Proven experience with Design History File (DHF), Device Master Record (DMR), and global regulatory standards (e.g., ISO 13485, FDA).
• In-depth knowledge of regulatory and product-specific requirements for sterile single-use products.
• Ability to define, optimize, and maintain information structures and documentation processes in a PLM environment.
• Ability to organize complex documentation efficiently, prepare audits, and ensure a transparent project structure.
• Confident presence as a point of contact for auditors and project teams, including coordinating audit preparations and interdisciplinary collaboration.
• Excellent English skills.

Benefits

• Flexible working hours & remote work: In many areas, working time and location can be arranged as needed.
• 30 vacation days plus various additional payments.
• Training opportunities: Open in-house seminar program, extensive e-learning offerings, professional development and more.
• Corporate benefits programs and bicycle leasing.
• Subsidy for private retirement provision and company health management.
• Various childcare options – at the headquarters in Tuttlingen.
• Health, sports, cultural and leisure offerings – these vary by location.