Design Quality Engineer - Medical Diagnostics & Compliance

Werfenlife SA.

Cataluña

Presencial

EUR 55.000 - 75.000

Jornada completa

Hace 4 días

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Descripción de la vacante

Werfen seeks a Quality Assurance professional to ensure Biokit products meet all Quality requirements and are documented in compliance with applicable regulations. The role provides quality oversight for development and commercialization of new assays and post‑market design changes for assays.

Key responsibilities include guiding Design Control and Change Control, maintaining the Quality System, preparing documentation for regulatory submissions, and collaborating with R&D, Regulatory Affairs,

Formación

Bachelor's degree in Life Sciences, Engineering, or Physical Science.
Degree may be substituted by relevant skills and work experience.
Valuable: any higher degree beyond the minimum.
Knowledge of quality standards including design control and validation; ASQ certifications are a plus.

Responsabilidades

Provide Design Control / Design Change Control guidance to development teams and manage risk.
Ensure assays comply with Product Development process and Quality System and regulatory requirements.
Create documentation to support regulatory submissions and risk management.
Collaborate with R&D, Quality Operations, Regulatory Affairs and Operations to meet goals and regulatory plans.
Lead design control training and continuous improvement of DQ processes, tools and standards.
Support regulatory inspections and ensure QA review of external communications.