Job Overview
Company
Katalyst HealthCares & Life Sciences
Ready to Apply?
Take the Next Step in Your Career
Join Katalyst HealthCares & Life Sciences and advance your career in Engineers
Apply for This Position
Click the button above to apply on our website
Job Description
Job Description:
In this role, you'll ensure manufacturing processes meet quality and regulatory standards while driving improvements across production and compliance.
This is a hands-on role with strong cross-functional collaboration and an emphasis on risk management, validation, and problem-solving.
Responsibilities: Support metrology, process mapping, pFMEA, control planning, validations, CAPA, NC, and change management.
Assist in reviewing and implementing changes to commercialized products.
Conduct failure investigations and root cause analysis.
Apply statistics and data analysis to support key decisions.
Partner with engineering, logistics, quality, and program management to meet system requirements.
Ensure compliance with ISO, FDA, and company quality standards.
Requirements: –+ years in medical device manufacturing (ISO, CFR, ISO, IEC, IEC).
Bachelors in engineering or Life Sciences (master's preferred).
Background in manufacturing transfer, process validation, and sustaining mechanical/software-driven devices.
Experience with risk management activities, inspection planning, and test method validation.
Technical skills in computational tools & electronic QMS.
Strong communicator, fast learner, thrives in dynamic environments.
Six Sigma (DMAIC) or Lean training/experience.
Excellent collaboration & communication skills.
About Katalyst HealthCares & Life Sciences
Don't Miss This Opportunity!
Katalyst HealthCares & Life Sciences is actively hiring for this Manufacturing Quality Engineer position
Apply Now