- Ensure products developed by Biokit meet all Quality requirements and comply with applicable regulations
- Provide quality oversight for development and commercialization of new assay products and post-commercialization design changes
- Provide Design Control and Design Change Control guidance, including risk management and regulatory strategies
- Ensure assays comply with the Product Development process, Biokit Quality System, and worldwide design control regulations
- Prepare documentation supporting worldwide regulatory submissions, product risk management, and design history
- Collaborate with R&D;, Quality Operations, Regulatory Affairs, and Operations to meet project goals and complete regulatory submissions
- Apply a risk-based approach to validation and implementation of product changes
- Provide Quality Oversight to non-conformance investigations, root cause investigations, and CAPA
- Ensure documentation is QA reviewed before sharing with regulators or customers
- Lead continuous improvement of DQ processes, standards, tools, and techniques
- Design and deliver training on design control
- Collaborate with QRA, R&D;, and Operations for successful Regulatory Inspections

Requirements

- Bachelor's degree (Diplomatura) in Life Sciences, Engineering, or Physical Science; relevant skills and work experience may substitute for the degree
- Minimum of 3 years in a similar position
- Fluency in Office Tools (Excel & Word)
- Basic knowledge in SAP is valuable
- Fluency in Spanish or Catalan
- Advanced knowledge of English (reading and speaking)
- Knowledge of Quality standards, including design control and validation




- Certifications such as ASQ–CQA, ASQ-CQE, ASQ-SWQE, ASQCQM, Process Excellence are valuable
- Ability to manage decisions under pressure
- Methodical and well-organized
- Time management skills
- Ability to express information clearly and concisely
- Ability to apply a systematic approach and control, follow up, and verify results
- Ability to collaborate, participate, and coordinate actively with working groups

Core Competencies

Demonstrates expertise in Quality Oversight, Design Control, and regulatory compliance for assay products, with a strong focus on risk management and continuous improvement processes. Proficient in collaborating across departments to ensure successful regulatory submissions and adherence to quality standards.

Highest-signal resume keywords

- Quality Oversight
- Design Control
- Regulatory Compliance
- Risk Management
- Continuous Improvement

Hard Skills

- Quality Standards
- Design Change Control
- Validation
- Regulatory Submissions
- Documentation Preparation
- Root Cause Investigation
- CAPA
- Project Management
- Assay Development
- Product Risk Management

Soft Skills

- Time Management
- Methodical Organization
- Clear Communication
- Collaboration
- Decision-Making Under Pressure

Certifications & Qualifications

- ASQ–CQA
- ASQ-CQE
- ASQ-SWQE
- ASQCQM
- Process Excellence

Industry Keywords

- Biokit Quality System
- Worldwide Design Control Regulations
- Non-Conformance Investigations
- Regulatory Inspections
- Assay Products

Tools & Technologies

- Office Tools
- Excel
- Word
- SAP

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📌 Design Quality Engineer (Lliçà d'Amunt)
🏢 Jobtailor
📍 Lliçà d'Amunt