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- 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

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- 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. xqbhyrx Proficient in collaborating across departments to ensure successful regulatory submissions and adherence to quality standards.

Highest-signal resume keywords

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- Quality Oversight

- Design Control

- Regulatory Compliance

- Risk Management

- Continuous Improvement

Hard Skills

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- Quality Standards

- Design Change Control

- Validation

- Regulatory Submissions

- Documentation Preparation

- Root Cause Investigation

- CAPA

- Project Management

- Assay Development

- Product Risk Management

Soft Skills

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- Time Management

- Methodical Organization

- Clear Communication

- Collaboration

- Decision-Making Under Pressure

Certifications & Qualifications

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- ASQ–CQA

- ASQ-CQE

- ASQ-SWQE

- ASQCQM

- Process Excellence

Industry Keywords

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- Biokit Quality System

- Worldwide Design Control Regulations

- Non-Conformance Investigations

- Regulatory Inspections

- Assay Products

Tools & Technologies

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- Office Tools

- Excel

- Word

- SAP

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📌 Design Quality Engineer (Llissá de Munt)
🏢 Jobtailor
📍 Llissá de Munt