Quality EngineerManufacturing; FDA Remediation Support

Quality Engineer Manufacturing (FDA Remediation Support)

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• 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.

• 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.

Mid-Senior level

Full-time

Quality Assurance

• Biotechnology Research
• Retail
• Appliances, Electrical, and Electronics Manufacturing