Design Quality Engineer - Medical Diagnostics & Compliance

Werfenlife SA.; Cataluña; On-site; EUR 55,000 - 75,000; Full time

Job summary

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,

Qualifications

• 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.

Responsibilities

• 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.

Skills

Excel

Word

SAP

Spanish/Catalan

English

Quality standards

Education

Bachelor's degree in Life Sciences/Engineering/Physical Science

Tools

None

Job description

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,