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Total Job Openings : 5
Manage specification, qualification and validation requirements.
Write and execute engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, updates to design history files. Conduct Risk based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Create, and update Failure Mode and Effect Analysis (DFMEA) for new implants and instruments.
Design, develop and oversee validation components and work on inspection plans and Inspection Feature Assessment.
Skills required: Auto Cad, Matlab, Kaizen, Minitab, Tally, Catia, Python, Ansys and Gap Analysis.
Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biotechnology Engineering, Science, Technology, or Engineering (any) with 5 years of experience in job offered or related occupation is required.
Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.
Gather and analyze information for product codes, device description, FDA listing numbers and GMDN codes.
Design, develop, test, document & support of cGxP systems as per 21CFR Part11 & US FDA.
Responsible for qualification & validation (IQ/OQ/PQ), master plans, protocols, changes requests, gap & root cause analysis, risk management plans, traceability matrix, summary reports for facilities, equipment, systems & processes.
Prepare, review, authorize & submission of documentation for quality compliance & regulatory authorities. Skills required: EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD.
Bachelor’s degree in Pharmaceutical Science, Pharmacy, Chemistry, Regulatory Affairs, Biology, Health Science, Science, Technology, or Engineering (any) with 5 years of experience in job offered or related occupation is required. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.
Work on product performance specifications and design changes.
Create, and update Failure Mode and Effects Analysis (DFMEA) for new implants and instruments. Implement CAPA actions to prevent nonconformance relating to the product, process, and operating standards.
Develop Approaches and methodologies based on new Medical Device Regulation requirements.
Perform internal audits in support of ISO standards. Skills Required: CAPA, Six Sigma, Gap Analysis, ISO 9001, ISO 13485, FMEA, DFMEA & PFMEA, DOE, IQ, OQ, PQ, and Kaizen.
Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biotechnology Engineering, Science, Technology, or Engineering (any) with 5 years of experience in job offered or related occupation is required.
Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.
Analyze, design and develop computer software applications.
Convert user requirements and project specifications to detailed flow charts for coding.
Develop web applications, database programming for generating dynamic web content.
Perform code review, test code deliverables, and migrate code to production environment.
Perform troubleshooting, identify defects, and fix them.
Skill required: C#, .NET, CSS, JSON, XML, HTML, Python, Eclipse and SQL Server.
Bachelor’s degree in Science, Technology, or Engineering (any) with 5 years of experience in job offered or related occupation is required.
Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.
Analyze, design and develop computer software applications. Convert user requirements and project specifications to detailed flow charts for coding.
Develop web applications, database programming for generating dynamic web content.
Perform code review, test code deliverables, and migrate code to production environment.
Perform troubleshooting, identify defects, and fix them. Skill required: Java, J2EE, Oracle, AWS, PL/SQL, UNIX, AJAX, MVC and Maven.
Bachelor’s degree in Science, Technology, or Engineering (any) with 5 years of experience in job offered or related occupation is required.
Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S