The "Quality Systems Specialist" shall have experience directing, implementing, and maintaining quality management system design and improvement activities to assure product quality and safety. This individual must be able to demonstrate significant experience drafting and implementing quality system policies and procedures in the medical device industry. Responsibilities: Assist in the design, implementation, and improvement of the company's Quality Management System, Manufacturing's Quality pro... more detailsgrams and policies. Ensures policies and procedures for assuring that the quality and compliance requirements of the company are being followed during lifecycle management execution. Provide Quality support and direction to project teams, complaint investigations and/or design change management. Ensure device design and development meets appropriate regulatory requirements by providing pro-active guidance through all stages of development in accordance with 21 CFR 820 and ISO 13485. Partner with project teams, as required, in the resolution of Corrective and Preventive Action (CAPA) and complaints. Review and approve deviations, OOS, and perform complaint investigations. Ensure risk management activities are developed in accordance with ISO 14971 procedures. Responsible for communication and escalation of quality issues within the company. Provide Quality oversight of Manufacturing facilities, utilities, equipment, computer system validations and change controls. Support Management & Quality Review meetings as required. Perform internal audits against GXP standards for 21 CFR 820, ISO 9001, ISO 13485, ISO 17025 and ISO 14971, lead vendor audits and CAPA approvals. Responsible for communication and escalation of vendor-related quality issues within Enzo. Batch record review and disposition of GMP/ IVD products. Prepare manufacturing personnel and all manufacturing related operations for regulatory inspections (FDA and ISO) and certifications for standard compliances. Develop and maintain quality systems, processes and procedures. Develop and enforce processes and procedures to ensure quality and compliance with professional standards. Compile, analyze, trend and present QMS metrics. Requirements: Education: BS in a scientific discipline. Experience: 3 years experience of working in a QA, QC, QS, GMP Manufacturing or Medical Device role. Skills: Thorough understanding and application of GXP specifically 21 CFR 820, ISO 9001, ISO 13485, ISO 17025 and the principles and concepts of relevant quality processes and systems; Experience interacting with FDA investigators and other regulatory agencies audits; Knowledge and application of device root cause analysis methodology and device CAPA requirements; Strong communication skills; Comfortable working and making risk-based decisions; Develop good working relationships with diverse teams; Dedicated to problem solving and meeting the expectations of internal and external customers; Ability to lead and deliver in a matrix environment; Prior experience of SOP interpretation and performing gap analysis; Understanding of device quality system principles, QMS, LMS & ability to translate into operational use. The salary range estimated for this position based in New York is $ 68'000 to $ 80'000
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