Design Quality Engineer: Quality by Design & Compliance

Werfen Immunoassay; Lliçà d'Amunt; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Werfen Immunoassay is seeking a Quality Lead to ensure Biokit products meet all quality requirements from development through post-launch changes. You will guide design control and change control, lead risk management, and prepare documentation for worldwide regulatory submissions, collaborating with R&D, Regulatory Affairs, and Operations.

The role requires a Bachelor's degree in Life Sciences or related field and at least 3 years of experience, with fluency in Spanish or Catalan and advanced

Formación

• Bachelor's degree (Diplomatura) in Life Sciences, Engineering, or Physical Science.
• Degree may be substituted by relevant skills and work experience.
• Valuable: Any additional degree higher than that required previously.

Responsabilidades

• Provide Design Control / Design Change Control guidance to product development teams, including risk management and regulatory strategies and plans.
• Ensure assay developed by Biokit complies with Product Development process & Biokit Quality System and worldwide design control regulations.
• Key outputs include: documentation to support regulatory submissions, product risk management, and design history.
• Ensure effective partnering with R&D, Quality Operations, Regulatory Affairs and Operations to meet project goals and submissions.
• Partner with R&D teams ensuring a risk-based approach to validation and implementation of product changes while maintaining Quality System.
• Provide Quality Oversight to non-conformance, root cause investigations and CAPA.
• Ensures that all documentation is QA reviewed before it is shared externally with regulators and/or customers.
• Lead activities to improve DQ processes, standards, tools, and techniques to meet external standards.
• Designs and delivers training to develop competency regarding design control.
• Collaborates with other QRA groups, R&D, and Operations to ensure regulatory inspections.

Conocimientos

Fluency in Office Tools (Excel & Word)

Spanish or Catalan fluency

Advanced English (reading and speaking

Quality standards knowledge

Teamwork

Educación

Bachelor's degree (Diplomatura) in Life Sciences, Engineering, or Physical Science

3 years in a similar position

Herramientas

SAP

Descripción del empleo

Werfen Immunoassay is seeking a Quality Lead to ensure Biokit products meet all quality requirements from development through post-launch changes. You will guide design control and change control, lead risk management, and prepare documentation for worldwide regulatory submissions, collaborating with R&D, Regulatory Affairs, and Operations.

The role requires a Bachelor's degree in Life Sciences or related field and at least 3 years of experience, with fluency in Spanish or Catalan and advanced