Quality Engineer

Katalyst HealthCares & Life Sciences

Job-ID Reference Job Description:
We are looking for an experienced CAPA Quality Engineer to drive CAPA initiatives, support project management activities, and communicate effectively across teams. The ideal candidate brings a minimum of five years of relevant experience and can quickly add value from day one. Responsibilities: Heavy focus on CAPA(Corrective & Preventive Action) execution. Own CAPA records from investigation through closure. Perform root cause analysis, issue assessment, and quality problem-solving. Manage a portfolio of CAPAs end-to-end. Partner with CAPA owners / cross-functional teams. Conduct investigations + drive closure activities. Review data sources and ensure thorough documentation/compliance. Must-Have Skillset: Strong CAPA background (non-negotiable). ISO 13485 experience (medical device/regulatory environment). Technical/STEM background. Proven communication skills (highly emphasized due to fast-paced environment). Ability to work independently and hit the ground running . Nice-to-Have: Project management experience (tracking, prioritization, coordination). Traits for Success: Strong communication + stakeholder management (critical). Ability to handle multiple CAPAs simultaneously. Detail-oriented with strong quality systems mindset. Qualifications: Must have Engineering degree- Technical experience and STEM related background.

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