Quality Engineer II - Fairfield, NJ - (Fairfield, NJ)

Job overview: Provides technical support to engineering teams for the quality assurance function. Job Info: Ensure Quality System is run by current regulation 21 CFR 820, 803, 806, 807 and ISO 13485. Work within Quality to assist in maintaining cGMP compliance for products manufactured, packaged, tested and released. Work with R&D on new product launches and commercial projects and ensure they are in line with cGMP qualifications. Write and review in investigations, CAPAs, FIRs, NCMRs, SCARs, HHEs, Change Notices and any additional QA documentation functions necessary to run the business. Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate. Provide support to manufacturing for WIP on the manufacturing floor. Support Quality Management during audits and inspections. Strengthen quality awareness, throughout the organization, support technical services, and process improvements. Ensure that proper document control is handled for facility.