CAPA Engineer Lead

hace 2 semanas

Alajuela, Alajuela, Costa Rica CooperCompanies A tiempo completo

The role of Principal CAPA Engineer will have responsibility for leading the site Corrective Action and Preventive Action (CAPA) Program at CooperSurgical. The incumbent will have the opportunity to apply knowledge and experience to ensure compliance to the quality and regulatory requirements for CAPA.

Key Responsibilities:

  • Evaluate CAPA initiation, investigation, action execution, effectiveness, and robust CAPA documentation.
  • Support CAPAs across different departments to ensure they are on track.
  • Develop and execute global CAPA procedures and policies.
  • Drive rigor in CAPA phases by coaching CAPA owners on the CAPA process, ensuring compliance with legal and ethical standards.
  • Develop, analyze, and report on CAPA metrics and maintain the CAPA log.
  • Ensure CAPA records are robust, timely, and compliant with the CAPA process.
  • Provide training on successful CAPA root cause investigation, corrective action execution, and effectiveness checks.
  • Maintain CAPA guidance material by keeping content up to date for training and onboarding.
  • Lead CAPA reviews and coach CAPA owners on planning, implementing, and documenting CAPA records.
  • Complete other CAPA and quality-related functions and projects as assigned.
  • Manage NCMR process to ensure a robust process development throughout the organization.
  • Collaborate with the Quality System Manager to ensure quality objectives are met and inform the organization of any limits or trends.
  • Establish follow-up meetings on action plans to eliminate trends of out-of-bounds objectives.

Qualifications:

  • University degree in Biomedical Engineering or technical discipline with a minimum of 6 years of experience in the Medical Device Industry.
  • Minimum of 5 years of experience working with CAPAs in the medical device industry.
  • Project Management Certification is a plus.
  • Experience managing projects at a global level in a regulated environment.
  • Experience with 21 CFR 820, ISO 13485, EU MDR.
  • Six Sigma Green Belt or above.
  • Leadership ability to coordinate work with multiple areas and influence cross-functional teams.
  • Strong technical and decision-making skills.
  • Ability to provide critical review and feedback on quality records.

CooperSurgical is an equal opportunity employer and does not discriminate against any employee or applicant for employment based on race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic characteristic, or other characteristics protected by law.

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