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
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
Welcome to Job Abstracts
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.