Senior Quality Assurance Specialist

Job Duties/Responsibilities

• Manage quality support activities for manufacturing and act as key quality contact for discrepancy management including Nonconformance (NC) and Corrective Action/Preventive Action (CAPA) systems.
• Ensure compliance with applicable regulations (FDA 21 CFR, ISO 13485, and other applicable domestic and global standards).
• Ensure that NC/CAPA investigations are accurate, include appropriate corrections, problem statement, root cause analysis, corrective/preventive actions, follow regulations, industry guidelines and company standards.
• Update the eQMS system for logging NC/CAPA and execute on deliverables to drive improvements.
• Manage key performance indicators (KPI’s) and present results to management and other stakeholders.
• Develop tools for and perform internal process audits to assess compliance with standard operating procedures.
• Support external notified body audits and FDA inspections as a technical resource and quality subject matter expert.
• Provide quality oversight related to operational activities, procedures, and processes including review and approve validation protocols, calibration records, analytical reports, and equipment maintenance records.
• Create and improve processes for quality and compliance using in-depth knowledge in the manufacturing and quality functional areas.
• Monitor and evaluate process controls, supplier quality, and product conformity.
• Provide quality systems, policy, and process training and support to team members.
• Lead quality issue resolution across manufacturing operations, support groups, and/or projects as needed.

Requirements

• Bachelor’s degree preferably in life sciences, engineering, or related field or the equivalent combination of education and experience.
• Minimum of 8 years of experience working in quality assurance required.
• Experience in the medical device or pharmaceutical industry required.
• Solid understanding of regulatory requirements in medical device manufacturing according to FDA 21CFR, ISO 13485, and MDSAP required.
• Good Manufacturing Practices certification required.
• Strong analytical and problem-solving skills and demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance.
• Possess a deep understanding of quality systems and quality assurance concepts.
• Previous work experience in a radiologically safe environment preferred.
• Must be excellent with details and possess strong documentation and organizational skills.
• Able to collaborate effectively and tactfully regarding complex and sensitive information.
• Able to establish and maintain effective working relationships relevant with cross functional teams.
• Able to multi-task and work within deadlines.
• Able to read and interpret Standard Operating Procedures (SOPs) and work instructions.
• Must be able to perform basic mathematical functions using whole numbers, fractions, and decimals and compute averages, rates, percentages, and draw and interpret graphs.
• Excellent written and verbal communication skills.
• Proficient in using Microsoft office programs (Outlook, Word, Excel, and PowerPoint).
• Willingness to work a flexible schedule.
• Satisfactory background screening.
• Satisfactory drug screening (if applicable to position).