Quality Design Engineer: Regulatory & Risk Leader

Actual Talent; Lliçà d'Amunt; On-site; EUR 60,000 - 90,000; Full time

Job summary

Biokit seeks a Quality Assurance / Regulatory Affairs professional to oversee design control and ensure regulatory compliance for new and existing assays. You will collaborate with R&D, Regulatory Affairs, and Operations to deliver compliant documentation and successful inspections.

The role emphasizes risk management, change control, and continuous improvement of quality systems, requiring fluency in Spanish or Catalan and strong English proficiency.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or Physical Science.
• Minimum 3 years in a similar position.
• Fluency in Spanish or Catalan; advanced English.
• Qualitative knowledge of Quality standards, design control, and validation.

Responsibilities

• Provide Design Control/Design Change guidance to product teams, including risk management and regulatory plans.
• Ensure assay development complies with Product Development process and Quality System.
• Contribute to regulatory submissions and risk management documentation.
• Collaborate with R&D, Regulatory Affairs, and Operations to meet project goals.
• Support CAPA processes and non-conformance investigations.

Skills

Excel

Word

SAP

English Proficiency

Spanish

Catalan

Education

Bachelor-level degree in Life Sciences/Engineering/Physical Science

ASQ Certifications (CQA/CQE/SWQE/QC)**

Tools

SAP

Job description

Biokit seeks a Quality Assurance / Regulatory Affairs professional to oversee design control and ensure regulatory compliance for new and existing assays. You will collaborate with R&D, Regulatory Affairs, and Operations to deliver compliant documentation and successful inspections.

The role emphasizes risk management, change control, and continuous improvement of quality systems, requiring fluency in Spanish or Catalan and strong English proficiency.