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

📌 Design Quality Engineer (Madrid)
🏢 Jobtailor
📍 Madrid