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Focal One

Quality Engineer

Focal One

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

Posted 10/21/2026full-timeVaulx-en-Velin • FranceSeniorLeadWebsite

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 document management, non-conformity tracking, and continuous improvement processes. Proficient in conducting audits and supporting product development while ensuring compliance and quality standards are met.

Highest-signal resume keywords
ISO 13485 KnowledgeQuality Management System AdministrationCAPA 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 ManagementNon-Conformity TrackingAnalytical SkillsReport WritingQuality Tools Proficiency
Soft Skills
Attention to DetailInterpersonal SkillsMethodical ApproachStrong Written CommunicationAnalytical Mindset
Tools & Technologies
Electronic Document Management SystemQuality Management SoftwareOffice Software
Industry Keywords
CAPAAuditsContinuous ImprovementProduct DevelopmentChange Management

About the role

Key responsibilities & impact
  • Contribute to maintaining and improving the Quality Management System (ISO 13485)
  • Monitor non-conformities, 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 non-conformity tracking system
  • Support product development 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
  • Provide cross-functional support within the Quality Department

Requirements

What you’ll need
  • Master’s degree (or equivalent, Bac+5) in Quality Management or a related field
  • At least 9 years of professional experience in a similar position
  • Knowledge of ISO 13485 is a significant advantage
  • Strong written and spoken English skills
  • Proficiency in office software
  • Ideally, initial experience with quality tools such as CAPAs, audits, and non-conformity tracking
  • Analytical mindset and strong attention to detail
  • Methodical approach and strong writing skills
  • Excellent interpersonal skills
  • Proficiency with IT tools and quality management software
  • Ability to write clear, well-structured reports

Benefits

Comp & perks
  • Additional leave days (RTT)
  • Meal vouchers
  • Company health insurance covering 65% of the cost
  • Sustainable mobility allowance
  • 50% reimbursement of public transport subscriptions
  • Remote-work agreement allowing employees, subject to certain conditions and manager approval, to work from home up to 2 days per week after the probationary period