What are the responsibilities and job description for the Quality Engineer � Manufacturing (FDA Remediation Support position at Katalyst CRO?
Job Description
- Our client is a large medical device manufacturer addressing FDA-driven remediation needs within manufacturing operations.
- They are seeking an experienced, fully onsite Quality Engineer to support process risk, validation, inspection, and control-plan development activities.
- Develop manufacturing control plans aligned with FDA and internal quality requirements.
- Create and update Master Validation Plans and Test Method Validations (TMVs).
- Develop and refine inspection procedures for manufacturing processes and incoming components.
- Create and update pFMEAs and process risk assessments to support remediation activities.
- Support manufacturing quality initiatives tied to FDA findings and compliance gaps.
- Collaborate with manufacturing engineering to ensure process controls, inspection methods, and validation activities meet regulatory expectations.
- 8 years Quality Engineering experience.
- Medical Device Manufacturing.
- Control Plan Development.
- Master Validation Plans / TMVs.
- Inspection Procedure Development.
- PFMEA / Process Risk Assessments.