Design Quality Engineer
Job Information
About the Position
Introduction
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 operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Overview
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.
Responsibilities
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.
Internal Networking
- To be determined based on department needs, to include interactions such as:
- Operations Area
- R&D Area
- Sales & Marketing
Qualifications
Minimum Knowledge & Experience required for the position
- Degree/studies
- 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.
- Years of experience
- Minimum of 3 years in a similar position.
- Min 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.
Skills & 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.
Travel Requirements
Not required
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
www.werfen.com
