Lead Quality Engineer

Katalyst Healthcares & Life Sciences • Fort Wayne, IN, US • published 2026-09-19 05:37:23.283971

Description

**Job Description:** We are seeking an experienced Lead Quality Engineer to provide technical leadership for quality engineering activities within a regulated manufacturing environment. The role will lead quality improvement initiatives, validation activities, risk management, CAPA, nonconformance investigations, supplier quality, and new product development while ensuring compliance with applicable FDA, ISO, GMP, and quality system requirements. **Responsibilities:** * Lead and provide technical direction for Quality Engineering activities across manufacturing and product development. * Develop, implement, and maintain quality plans, procedures, and engineering controls. * Lead CAPA, nonconformance, deviation, complaint, and root cause investigations. * Support and lead process validation, equipment qualification, and test method validation activities. * Develop and review PFMEA, DFMEA, risk assessments, control plans, and inspection plans. * Support Design Controls, Verification \& Validation (V\&V), NPI, and Design Transfer activities. * Lead continuous improvement initiatives using Lean, Six Sigma, SPC, DOE, and statistical analysis. * Monitor process capability, quality metric...

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