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Quality Engineer

Job

Katalyst Healthcares & Life Sciences

Cambridge, MA (In Person)

Full-Time

Posted 4 days ago (Updated 1 day ago) • Actively hiring

Expires 6/25/2026

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Job Description

Quality Engineer Katalyst Healthcares & Life Sciences - 4.0 Cambridge, MA Job Details Contract 1 day ago Qualifications Corrective and preventive actions (CAPA) Biomedical regulatory compliance Regulatory compliance analysis
ISO 13485
Stakeholder relationship building Stakeholder management
Full Job Description 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.