Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. We operate directly in 30 countries, and in more than 100 territories through distributors.
Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong.
JOB SUMMARY
The position is responsible for ensuring that products developed by Biokit meet all Quality requirements and are documented in compliance with all applicable regulations. The position provides quality oversight for the development and commercialization of new assay products in addition to post commercialization design changes for assays.
Key Accountabilities
Provide Design Control / Design Change Control guidance to internal or external product development teams, including risk management and development of regulatory strategies and plans.
The role will ensure that assay developed by Biokit in compliance with the Product Development process & Biokit Quality System and worldwide design control regulations.
Key outputs include: documentation to support efficient worldwide regulatory submissions, product risk management, and comprehensive design history.
Ensure effective partnering and collaboration with R&D, Quality Operations, Regulatory Affairs and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions.
Partner with the R&D teams ensuring a risk-based approach to the validation and implementation of product changes to existing products while maintaining compliance with Quality System elements, including but not limited to: Design Control, Design Change, Risk Management and Change Control.
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 continuously improve DQ processes, standards, tools, and techniques to ensure they effectively and efficiently meet external standards.
Designs and delivers appropriate training to develop the overall competency of the organization regarding design control.
Collaborates with other QRA groups, R&D, and Operations to ensure successful Regulatory Inspections.
Networking / Key Relationships
To be determined based on department needs, to include interactions such as:
Operations Area
R&D Area
Sales & Marketing
Minimum Knowledge & Experience Required for the Position
Education
Required: 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.
Experience
Minimum of 3 years in a similar position.
Additional Skills / Knowledge
Software: Fluency in Office Tools (Excel & Word). Valuable: Basic knowledge in SAP.
Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking).
Standards: Knowledge of Quality standards, including design control and validation. Certifications include ASQ–CQA, ASQ-CQE, ASQ-SWQE, ASQCQM, Process Excellence.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities
The ideal candidate for this position will exhibit the following skills and capabilities:
Management of decisions under pressure.
Methodical and well-organized person.
Teamwork.
Time management skills.
Ability to express information clearly and concisely to the staff, ensuring their understanding.
Ability to apply a systematic approach and constant control, follow-up and verification of the results.
Ability to collaborate, participate and coordinate actively with working groups.
Reflects values of Werfen in the quality of work and working relationship.