Gandiv Insights LLC · 10 hours ago
Senior Quality Engineer
New York, NY
Contract
Onsite
Mid, Senior Level
3+ years expGandiv Insights LLC is seeking a highly experienced Senior Quality Engineer to support validation, quality systems, and continuous improvement initiatives in an FDA-regulated medical device manufacturing environment. This role requires strong technical expertise, regulatory knowledge, and the ability to collaborate effectively with cross-functional teams.
Information Technology & Services
Responsibilities
Lead and execute validation activities including IQ, OQ, PQ, and MSA for equipment, processes, test methods, and computerized systems
Support and drive change control activities in compliance with FDA, cGMP, and ISO requirements
Serve as a primary quality representative during external audits and inspections
Lead process improvement initiatives focused on scrap reduction, defect reduction, and operational efficiency
Collaborate with production, quality, laboratory, engineering, and service teams to support quality objectives
Prepare, review, and maintain validation documentation, protocols, reports, and technical data analyses
Conduct root cause investigations and implement corrective and preventive actions
Mentor junior engineers and provide technical guidance during design, installation, qualification, and process monitoring
Support new process and technology development and implementation at the plant level
Qualification
Required
Medical device experience with strong knowledge of 21 CFR 820, FDA cGMP, and ISO standards
Experience with statistical analysis tools (Minitab preferred)
Knowledge of Lean Six Sigma and process improvement methodologies
Ability to read and interpret engineering drawings and technical documentation
Strong analytical, problem-solving, and root cause investigation skills
Excellent verbal and written communication skills
Proficiency in MS Word, Excel, PowerPoint, and quality databases
Ability to manage multiple projects and meet tight deadlines
Bachelor's degree in Engineering required
3–5 years of Quality Engineering experience in an FDA-regulated or medical device environment
Experience supporting or developing Quality Systems
Preferred
Master's degree in Engineering preferred
Experience with statistical analysis tools (Minitab preferred)
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase