Gandiv Insights LLC · 2 hours ago
Quality Assurance Specialist
Parsippany, NJ
Contract
Onsite
Senior Level
5+ years expGandiv Insights LLC is seeking a Quality Assurance Specialist to provide Quality Engineering support for medical device manufacturing. The role involves leading various quality assurance processes and maintaining documentation while ensuring compliance with industry standards.
Information Technology & Services
Responsibilities
Quality Engineering support for medical device manufacturing
Experience with ISO 13485, FDA 21 CFR Part 820, GMP
Hands-on with APQP, PPAP, PFMEA, Control Plans, MSA, SPC
Lead CAPA, deviations, nonconformance, and root cause analysis (5 Whys, Fishbone, 8D)
Support process validation (IQ/OQ/PQ) and First Article Inspections
Perform data analysis, trending, and continuous improvement
Support internal, supplier, and regulatory audits
Maintain manufacturing and quality documentation
Experience with inspection tools (calipers, micrometers, CMM)
Qualification
Required
Quality Engineering support for medical device manufacturing
Experience with ISO 13485, FDA 21 CFR Part 820, GMP
Hands-on with APQP, PPAP, PFMEA, Control Plans, MSA, SPC
Lead CAPA, deviations, nonconformance, and root cause analysis (5 Whys, Fishbone, 8D)
Support process validation (IQ/OQ/PQ) and First Article Inspections
Perform data analysis, trending, and continuous improvement
Support internal, supplier, and regulatory audits
Maintain manufacturing and quality documentation
Experience with inspection tools (calipers, micrometers, CMM)
5+ years of Quality Engineering experience (medical devices preferred)
Bachelor's degree in Engineering or related field
Strong documentation and communication skills
Proficient in MS Office
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