Validation and Quality Specialist (QA/QC)

Career

Validation and Quality Specialist (QA/QC)

We are looking for a validation and quality specialist (QA/QC) to join Explicell’s interdisciplinary R&D team and take part in delivering the CUSTOMED project within IPCEI Med4Cure.

Košice Place of work

Full-time Employment

ASAP Start

from €1,700 Base salary (gross)

The stated salary is the guaranteed minimum base salary. The exact amount will be agreed individually, depending on the selected candidate’s professional experience, knowledge and competencies.

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Duties and responsibilities

The CUSTOMED project brings together digital processing of patient data, personalised design, biofabrication, testing and validation. Quality, validation and evidence generation are an important part of its proposed architecture.

Your role will be to help set up how the quality of the project’s processes, data and outputs is verified, documented and demonstrated.

Your work will mainly include:

• Designing validation and testing strategies, plans and protocols

• Defining quality metrics and acceptance criteria

• Performing or coordinating testing, inspections and validation activities

• Evaluating results and preparing validation records and reports

• Identifying, documenting and handling deviations, including proposing corrective and preventive actions

• Ensuring the traceability, consistency and auditability of documentation and results

• Supporting the set-up of the quality and validation system for the individual outputs of the CUSTOMED project

Who we are looking for

Education

A master’s degree in a technical, biological, biomedical, natural-science or other relevant field.

What we expect

• Experience with validation, QA/QC, laboratory testing or a similar field
• Experience in preparing validation or test protocols and reports
• Knowledge of working with SOPs, deviations and corrective actions
• The ability to define acceptance criteria and evaluate results systematically
• A thorough approach to documentation, traceability and data quality
• Analytical and systematic thinking
• Independence and responsibility for assigned tasks and outputs
• The ability to work in an interdisciplinary R&D team
• A proactive approach to communication and problem-solving

Nice to have

• Experience with Quality by Design and risk-based validation principles
• Experience with medical imaging data, DICOM or segmentation
• Experience with Image-to-Design validation and patient-specific workflows
• Knowledge of quality metrics for segmentation and anatomical 3D models
• Experience with verifying CAD models, simulations or generative design
• Experience in creating verification and validation plans
• Experience with mechanical, biological or materials testing
• Knowledge of GLP, GMP or another regulated laboratory environment

What we offer

1. Direct involvement in delivering the CUSTOMED project within IPCEI Med4Cure, focused on developing solutions in personalised medicine

2. Work with the latest technologies and innovative solutions in biomedical research and 3D technologies

3. Work in an interdisciplinary environment, in collaboration with experts from technical, biological and medical fields

4. Room for professional growth, independence and initiative, including the opportunity to influence the quality and validation of the solutions being developed

5. A stable working background, a modern working environment and technological equipment

6. The opportunity to attend professional conferences, training and company events

Interested?

Validation and Quality Specialist (QA/QC)

mbartikova@explicell.sk

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Career 1

Other open positions

• Data Engineer / Software Developer

  • R&D
  • CUSTOMED

  Košice
  Full-time

  More Info Data Engineer / Software Developer

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Contact

Discuss Your Patient Case or Partnership

Tell us what you are planning. If you have CT or DICOM scans, mention it in your message and we will agree on a secure way to share them.

Sales and customer support

info@explicell.sk

Explicell, s.r.o.

Popradská 56/D
040 11 Košice, Slovakia

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