Senior Medical Device Quality Engineer - CAPA & Process Lead
Listed on 2026-10-06
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Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Katalyst CRO seeks an experienced Manufacturing Quality Engineer to lead quality assessments, remediation, validation, and continuous improvement within a regulated medical device manufacturing environment. You will drive FPY improvements, review IQ/OQ/PQ activities, and support risk management across supplier quality.
You will manage CAPA, nonconformances, and apply SPC, MSA, PFMEA tools while supporting FDA, ISO 13485, and MDSAP audits.
Step into the Senior Medical Device Quality Engineer - CAPA & Process Lead role at Katalyst CRO in Reedsville, PA, United States and grow with us.
The position is based in Reedsville, PA, United States.
This opportunity is part of our work in Engineering.
The advertised compensation is 95..
We aim to respond to suitable candidates as soon as possible.
Full responsibilities and requirements are described in the listing above.
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