Katalyst CRO · 1 month ago
Quality Engineer – Manufacturing (FDA Remediation Support
Bridgewater, NJ
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst CRO is a company focused on supporting FDA-driven remediation needs within manufacturing operations for medical devices. They are seeking an experienced Quality Engineer to develop control plans, validation plans, and inspection procedures to ensure compliance with regulatory expectations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
8+ years Quality Engineering experience
Medical Device Manufacturing
Control Plan Development
Master Validation Plans / TMVs
Inspection Procedure Development
PFMEA / Process Risk Assessments
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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