Quality Engineer Manufacturing (FDA Remediation Support

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. Experience needs:

8+ years Quality Engineering experience.

Medical Device Manufacturing.

Control Plan Development.

Master Validation Plans / TMVs.

Inspection Procedure Development.

PFMEA / Process Risk Assessments.