Design Quality Engineer

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

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.