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Senior Quality Improver (Quality Engineer)

CooperVision · Alajuela

Nouveau
Senior 🇬🇧 English
ISO 13485 QSR Statistical Techniques CAPA Risk Management Excel Word

Description du poste

About the role

CooperVision is seeking a Senior Quality Improver to lead the implementation, monitoring and continuous improvement of its Quality Management System across manufacturing sites. The role combines regulatory compliance, CAPA leadership and cross‑functional improvement initiatives to ensure product and process excellence.

Key responsibilities

  • Implement and monitor the Quality System, ensuring readiness for internal and external audits (MDSAP, LRQA, BSI Micro, etc.).
  • Lead CAPA investigations, manage NCRs, complaints and quality feedback, and evaluate effectiveness of corrective actions.
  • Execute and approve production and process changes, engineering studies, validation protocols and software/utility validations.
  • Perform risk assessments, HHE analyses and support calibration and out‑of‑tolerance investigations.
  • Develop and maintain quality KPIs, drive improvement actions and support operational excellence programs.

Required profile

  • Minimum five years of experience in Quality Engineering or related quality roles.
  • Bachelor’s degree in engineering, science or a related field, or equivalent experience.
  • Fluent in English and Spanish, with strong written and oral communication skills.
  • Proven leadership, problem‑solving and decision‑making abilities, and ability to work with self‑directed teams.

Required skills

  • Knowledge of QSR (Quality System Regulations) and ISO 13485.
  • Experience with statistical techniques and risk management methods.
  • CAPA management and root‑cause analysis.
  • Proficiency in Microsoft Excel, Word and PowerPoint.

Questions fréquentes

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CooperVision

Alajuela