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Focal One

Quality Engineer

Focal One

. Contribute to maintaining and improving the Quality Management System (ISO 13485) .

Posted 10/19/2026full-timeVaulx-en-Velin • FranceMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Management Systems, particularly ISO 13485, with a strong focus on continuous improvement, document management, and quality tools. Proficient in conducting audits and investigations while maintaining thorough documentation and effective communication.

Highest-signal resume keywords
ISO 13485 KnowledgeQuality Management System ExpertiseCAPA ManagementInternal AuditingDocument Management

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Quality ManagementDocument DraftingNonconformity TrackingAnalytical SkillsReport Writing
Soft Skills
Attention to DetailInterpersonal SkillsThoroughness
Tools & Technologies
Electronic Document Management SystemQuality SoftwareNonconformity Tracking System
Industry Keywords
Continuous ImprovementQuality IndicatorsSupplier AuditsChange Management

About the role

Key responsibilities & impact
  • Contribute to maintaining and improving the Quality Management System (ISO 13485)
  • Monitor nonconformities, CAPAs, and quality indicators
  • Contribute to document management, including drafting, reviewing, and approving documents
  • Administer quality tools, particularly the electronic document management system (EDMS) and nonconformity tracking system
  • Support product projects and change management activities
  • Conduct internal and supplier audits
  • Lead the qualification and validation of QMS tools and software, as well as production tools and processes
  • Participate in investigations related to complaints
  • Contribute to the continuous improvement of products
  • Strengthen the Quality Management System and support teams in a culture of continuous improvement

Requirements

What you’ll need
  • Master’s degree (Bac +5 equivalent) in quality management or a related field
  • Ideally, initial experience in a similar role
  • Knowledge of ISO 13485 is an advantage
  • Good written and spoken English
  • Proficiency in standard office software
  • Ideally, initial exposure to quality tools such as CAPAs, audits, and nonconformity tracking
  • Analytical mindset and strong attention to detail
  • Thoroughness and strong writing skills
  • Excellent interpersonal skills
  • Proficiency in IT tools and quality software
  • Ability to write clear, well-structured reports

Benefits

Comp & perks
  • Additional paid time off (RTT)
  • Meal vouchers
  • Health insurance covered at 65%
  • Sustainable mobility allowance
  • Public transportation subscription covered at 50%
  • Possibility of working remotely up to two days per week, subject to certain conditions and manager approval, following completion of the probationary period