Quality Engineer II at Heraeus Medevio developing engineering solutions for manufacturing complaints and quality issues. Leading teams to improve product and process quality in Cartago, Costa Rica.
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.
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