FUSTIS LLC · 11 hours ago
Supplier Quality Remediation Engineer (Multiple locations)
Marlborough, MA
Contract
Onsite
Senior Level
$44/hr - $55/hr
5+ years expFUSTIS LLC is seeking a Supplier Quality Remediation Engineer to support supplier remediation activities following an FDA 483 observation. This role will lead supplier gap assessments and remediation efforts, focusing on aligning design and process risk controls to regulatory expectations.
Staffing & Recruiting
Hiring Manager
Adarsh Jaiswal
Responsibilities
Lead supplier gap assessments and remediation efforts
Evaluate supplier process controls using advanced quality engineering methodologies
Ensure high-severity risks are appropriately identified, mitigated, and sustained in compliance with FDA and ISO requirements
Collaborate with suppliers to execute corrective actions
Review validation activities
Communicate findings and action plans to internal stakeholders
Qualification
Required
Bachelor's degree in engineering
5+ years of experience in medical device or other regulated manufacturing environments
Strong expertise in dFMEA and pFMEA (with emphasis on severity ratings)
Process capability analysis (cPk)
IQ/OQ/PQ
Measurement System Analysis
Hands-on collaboration with suppliers to execute corrective actions
Review validation activities
Communicate findings and action plans to internal stakeholders
Preferred
Experience supporting supplier remediation following regulatory observations
Working knowledge of FDA QSR
ISO 13485
ISO 14971
Blueprint reading
Statistical tools such as Minitab
Company
FUSTIS LLC
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11-50 employees
Funding
Current Stage
Early StageLeadership Team
Prateek Singh
Chief Information Security Officer
Company data provided by crunchbase