Quality Engineer

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants. Company: One of Our ClientsJob Description:Job Title: Quality Senior Engineer ILocation: Englewood, CO 80112Duration: 12+ Months (Extendable)Pay Rate: $45-$48.00/hr on W2DutiesReview, remediate, and migrate legacy CAPA records into EtQ to ensure completeness, accuracy, and compliance with global procedures.Manage assigned CAPAs through initiation, investigation support, action tracking, effectiveness verification, and closure.Perform gap assessments of CAPA records and support correction of documentation deficiencies to meet regulatory and internal quality system requirements.Partner cross-functionally with Quality, Regulatory, Operations, and Engineering to support CAPA execution and remediation activities.Support compliance to global CAPA procedures, including documentation standards, timeliness expectations, and record retention requirements.Assist with training and user guidance related to CAPA procedures and EtQ processes. SkillsWorking knowledge of CAPA processes, root cause analysis, and quality system requirements. Experience with electronic Quality Management Systems (EtQ preferred). Knowledge of applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and risk-based quality principles. Strong technical writing and documentation review skills. Strong organizational skills with high attention to detail and ability to manage multiple priorities. Analytical/problem-solving skills with ability to identify gaps and drive resolution. Ability to work cross-functionally and communicate effectively across levels of the organization. Proficiency with Microsoft Office (Excel, Word, PowerPoint) and document control systems.Medical device or other regulated industry experience preferred. EducationB.S. in engineering or an alternative Bachelor’s degree program3-5 years of experience required in a Quality Engineering role, preferably supporting CAPA processesKnowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 preferred.Knowledge of design controls, risk management, FMEA, CAPA, root cause investigation and statistical analysis.Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferredRegards,Prateek PampattiwarRecruitment SpecialistNet2Source Inc.Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USAOffice: (201) 340-8700 x 324 | Cell: (551) 220 3007| Fax: (201) 221-8131| Email: Pampattiwar.Prateek@net2source.com