Job Description
Job Summary We are seeking a dedicated and detail-oriented QA / RA (Quality Assurance / Regulatory Affairs) Specialist to ensure our products meet the highest standards of quality, safety, and regulatory compliance.In this vital role, you will oversee quality systems, conduct audits, and ensure adherence to international and local regulations such as ISO 13485, FDA regulations, and CGMP.Your proactive approach will help maintain our commitment to excellence in manufacturing and product integrity, supporting continuous improvement and customer satisfaction.Duties Maintain and control Quality Management System (QMS) documentation, including SOPs, forms, ECNs, and other quality records, ensuring accuracy, completeness, and compliance with applicable standards (e.g., ISO 13485, CGMP) Manage document lifecycle processes, including creation, review, approval, release, revision, distribution, and archival of controlled documents.Ensure change control processes are properly implemented, including coordination and tracking of Engineering Change Notices (ECNs).Maintain document control systems and manage access to ensure only current, approved versions are available at points of use, and that obsolete documents are appropriately archived.Review and approve quality-related documentation for compliance with internal procedures and applicable regulatory requirements.Support management of the calibration system, including tracking, scheduling, and maintaining calibration records to ensure equipment remains compliant and within required intervals.Assist in the proper handling and documentation of nonconformances, CAPAs, and related quality records, as needed.Conduct internal audit activities, maintain documentation and assist with audit preparation and follow-up actions.Provide support to Regulatory Affairs for product registrations, including compiling and organizing required technical documentation and maintaining submission records, as needed.(e.g., FDA, EU MDR, Health Canada) Assist in ensuring that labeling, IFUs, and other controlled materials are properly reviewed, approved, and maintained within the document control system.Perform other duties as assigned.Skills Familiarity with FDA 21 CFR Part 820, ISO 13485, EU MDR (2017/745), and risk management.Knowledge of commonly used concepts, practices, and procedures within FDA regulated industry.Proven experience conducting quality audits and inspections within manufacturing or healthcare environments.Excellent analysis skills to identify root causes of quality issues and develop effective corrective actions.Solid understanding of quality control processes, quality assurance practices, and quality management systems.Exceptional communication skills for clear documentation and collaboration across departments.Ability to adapt quickly to changing regulatory landscapes and implement necessary updates efficiently.Proficient in Microsoft Office Suite Required Education / Experience:Bachelor's degree in science, engineering, or regulatory and 2-3 years of experience in QA/RA, preferably in the medical device or pharmaceutical industry, or 5-7 years' experience in equivalent role in medical device or pharmaceutical industry.Pay:$65,000.00 - $75,000.00 per year Benefits:401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance Application Question(s):Do you currently possess valid and unrestricted U.S.work authorization? Candidates must answer 'yes' to be considered for this role.Individuals with temporary visas or any candidate requiring sponsorship, now or in the future, will not be considered for this role.Will you agree to a background check, post offer? Ability to Commute:Baldwin, NY 11510 (Required) Work Location:In person.