EOS imaging

Quality Assurance Engineer

EOS imaging

contract

Posted on:

Location Type: Hybrid

Location: Paris • 🇫🇷 France

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Job Level

Mid-LevelSenior

About the role

  • Release components and finished products
  • Product non-conformities and CAPA:
  • Document the results of non-conformity investigations as NC Owner
  • Support other departments in resolving product non-conformities as NC Mentor
  • Supplier management:
  • Participate in supplier evaluation and monitoring
  • Ensure the progress and documentation of supplier non-conformities in collaboration with Purchasing
  • Track improvement actions and supplier non-conformity records
  • Monitor daily supplier performance; participate in and provide data for the quarterly supplier review
  • Product documentation:
  • Assist other departments in the preparation of product documents (production/service file and associated records)
  • Metrology:
  • Ensure identification of the company's measuring equipment and their entry in the tooling database
  • Keep verification or calibration reports and metrology service provider certifications up to date, validate and file them
  • Promote the Quality approach within the company
  • Participate in document updates; assist other departments in preparing quality documents

Requirements

  • Education and experience: Graduate with a master's level (BAC+5) in a general program or in quality; you have initial experience in Quality Assurance in the healthcare industry
  • Competencies and required skills
  • Proficiency in English is essential for this position
  • Mastery of standards: ISO 13485 is required. 21 CFR 820, MDSAP and EU Regulation 2017/745 are desirable.
  • Excellent interpersonal skills to liaise with all internal and external stakeholders
  • Strong written accuracy and ability to synthesize are imperative
  • Autonomy, decision-making ability, and a sense of reporting

Applicant Tracking System Keywords

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

Hard skills
Quality AssuranceMetrologySupplier managementNon-conformity investigationsDocument preparationData trackingCalibrationProduct documentationQuality documentation
Soft skills
Interpersonal skillsWritten accuracySynthesis abilityAutonomyDecision-makingReporting
Certifications
ISO 1348521 CFR 820MDSAPEU Regulation 2017/745