Design Quality Engineer – Regulatory Submissions & Risk

Jobtailor; Lliçà d'Amunt; Presencial; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

Biokit seeks an experienced QA professional to provide Quality Oversight for assay product development and post-market changes. The role emphasizes design control, risk management, and regulatory submissions across global markets.

Responsibilities include guiding change control, overseeing documentation quality, and collaborating with cross-functional teams to ensure compliance with the Biokit Quality System and worldwide design control regulations.

Formación

• Bachelor's degree required or equivalent

Responsabilidades

• Ensure products meet Quality requirements and comply with regulations
• Provide quality oversight for development and commercialization of assay products
• Provide Design Control and Design Change Control guidance including risk management and regulatory strategies
• Ensure assays comply with Product Development process, Quality System, and worldwide design control regulations
• Prepare documentation supporting regulatory submissions, product risk management, and design history
• Collaborate with R&D, Quality Operations, Regulatory Affairs, and Operations to meet project goals
• Apply risk-based approach to validation and implementation of product changes
• Provide Quality Oversight to non-conformance investigations, root cause investigations, and CAPA
• Ensure documentation is QA reviewed before regulators or customers
• Lead continuous improvement of DQ processes, standards, tools, and techniques
• Design and deliver training on design control
• Collaborate for successful Regulatory Inspections

Conocimientos

Quality Oversight

Design Control

Regulatory Compliance

Risk Management

Continuous Improvement

Educación

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

Herramientas

SAP

Office Tools

Excel

Word

Descripción del empleo

Biokit seeks an experienced QA professional to provide Quality Oversight for assay product development and post-market changes. The role emphasizes design control, risk management, and regulatory submissions across global markets.

Responsibilities include guiding change control, overseeing documentation quality, and collaborating with cross-functional teams to ensure compliance with the Biokit Quality System and worldwide design control regulations.