Design Quality Engineer

Jobtailor; Lliçà d'Amunt; Presencial; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

Biokit seeks an experienced QA professional to provide Quality Oversight for assay product development and post-market changes. The role emphasizes design control, risk management, and regulatory submissions across global markets.

Responsibilities include guiding change control, overseeing documentation quality, and collaborating with cross-functional teams to ensure compliance with the Biokit Quality System and worldwide design control regulations.

Formación

• Bachelor's degree required or equivalent

Responsabilidades

• Ensure products meet Quality requirements and comply with regulations
• Provide quality oversight for development and commercialization of assay products
• Provide Design Control and Design Change Control guidance including risk management and regulatory strategies
• Ensure assays comply with Product Development process, Quality System, and worldwide design control regulations
• Prepare documentation supporting regulatory submissions, product risk management, and design history
• Collaborate with R&D, Quality Operations, Regulatory Affairs, and Operations to meet project goals
• Apply 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 regulators or customers
• Lead continuous improvement of DQ processes, standards, tools, and techniques
• Design and deliver training on design control
• Collaborate for successful Regulatory Inspections

Conocimientos

Quality Oversight

Design Control

Regulatory Compliance

Risk Management

Continuous Improvement

Educación

Bachelor's degree (Diplomatura) in Life Sciences, Engineering, or Physical Science

Herramientas

SAP

Office Tools

Excel

Word

Descripción del empleo

• 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