Quality Engineer Manufacturing; FDA Remediation Support
Job in
Bridgewater, Plymouth County, Massachusetts, 02324, USA
Listed on 2025-11-25
Listing for:
Katalyst CRO
Seasonal/Temporary
position Listed on 2025-11-25
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Process Engineer, Validation Engineer -
Manufacturing / Production
Quality Engineering, Manufacturing Engineer, Validation Engineer
Job Description & How to Apply Below
Quality Engineer Manufacturing (FDA Remediation Support)
Join to apply for the Quality Engineer Manufacturing (FDA Remediation Support role at Katalyst CRO
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.
Responsibilities- 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.
- Seniority level:
Mid‑Senior level - Employment type:
Contract - Job function:
Quality Assurance - Industries:
Pharmaceutical Manufacturing
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