Quality Systems Engineer

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.

Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We also develop clinical software applications and laboratory instrumentation systems enhancing patient care.

We operate directly in 30 countries, and in more than 100 territories through distributors. Our headquarters and technology centers are located in Europe and the United States, and our workforce is more than 7,000 strong.

In Werfen, our purpose is to contribute to the advancement of patient care around the world through innovative specialized diagnostics solutions. 

The OEM Business line is looking for a Quality Systems Engineer, whose main task is to ensure the company is compliance with all applicable regulations and standards. Is autonomous regarding audit organization and capable to conduct audits, being part of the subject matter experts (SME) as well, specially for the QS responsibilities . Participates in the continuous improvement of the QRA area, being supportive in the Non-conformance, Change Control and CAPA process enhancement and leaders the documental management system of the company.

Key Accountabilities

• Accountable for organizing External and Internal Audits.
• Backroom host while external audits
• Frontroom host while internal audits
• Responsible for the documental management system, and participation in the performance-qualification of any changes on the system.
• Documents of external origin accountability. Participates in the impact assessments, action plan definitions and follow up of the changes needed in the documental system.
• Change Order module responsible, ensuring GxP (good practices) and training to all workmates when needed. Also accountable for the process-qualification of any changes on the module.
• Controls and reports her/his own KPIs of the department.
• Leads/Owns Non Conformities, Change Controls and CAPA of the QS&C department.
• Responsible for the follow up of the Non conformances arisen over the audit process.
• Autonomous person to carry out project management, participating in the continuous improvement of the department.

Networking/Key relationships

This position requires to keep constant interaction with all the areas of the company, part of the job is to train other partners in the company.

Minimum Knowledge & Experience required for the position

Education:

• Required: Bachelor’s degree (Grado) in Chemistry, Biotechnology or other Sciences, complete with competency in chemical, biological, or health-related work experience. Degree may be substituted by relevant skills and work experience
• Valuable: Any additional degree higher than that required in the previous section, like master degree in electronic documental and record management system (EDRMS), and/or in Master degree in Quality.

Proven deep experience in the Key accountabilities will be a plus.

Experience:

• Minimum of 3 years in a similar role.

Additional Skills/Knowledge:

• Software:good knowledge of Microsoft Office and Adobe tools. Valuable Basic Knowledge in SAP experience, and provable capability to adapt to new technologies. Ability to digitalize processess will be taken into account.
• Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking).
• Standards: Deep knowledge of regulatory requirements in the area of medical devices and/or in-vitro diagnostics and quality management. Any other regulation/ standard knowledge will be a plus. 

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 sytematic 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 relationships

Competencies:

The ideal candidate for this position will exhibit the following skills and competencies:

• Managing Work
• Emotional Inteligence Essentials
• Building Partnership
• Decision Making
• Continuous Improvement
• Continuous Learning

Travel requirements:

Not required.