Senior QA Analyst – IVD / Medical Devices

Job Title: Senior QA Analyst – IVD / Medical Devices Location: Remote (Occasional onsite visits to NJ) Duration: 6+ Months (Potential Extensions) Company: United Pharma Technologies Industry: Medical device manufacturing Job Description: We are seeking an experienced Senior QA Analyst to provide quality oversight for In Vitro Diagnostic (IVD) devices, companion diagnostics (CDx), and laboratory-developed tests supporting clinical trials and commercial programs. The ideal candidate will have strong knowledge of medical device quality systems, regulatory compliance, and hands-on experience managing quality processes within regulated pharmaceutical, biotechnology, or medical device environments. Key Responsibilities: Provide quality oversight for IVD devices, companion diagnostics (CDx), and laboratory-developed tests used in clinical trials and commercial programs. Review Design History Files (DHF), technical documentation, verification and validation reports, and performance evaluation data for regulatory compliance. Support IVD performance studies in accordance with EU IVDR 2017/746 and FDA 21 CFR Part 820 / QMSR requirements. Maintain and improve quality management system (QMS) processes, including SOPs, work instructions, and controlled documentation. Manage and track deviations, CAPAs, change controls, and nonconformances related to diagnostic products and external partners. Support risk management activities and quality reviews in alignment with ISO 14971. Assist with qualification and ongoing monitoring of diagnostic partners, testing laboratories, and suppliers. Support quality agreements, supplier performance monitoring, and supplier audits. Prepare for and participate in internal audits, notified body audits, and FDA inspections. Support complaint investigations, trend analysis, and vigilance reporting for IVD products. Prepare quality metrics and reports for management reviews. Serve as a quality contact for Regulatory Affairs, Clinical Operations, and Medical Affairs teams. Provide training on IVD quality systems and applicable regulatory requirements Required Qualifications: Bachelor's degree in Life Sciences, Biomedical Engineering, or a related discipline. 5+ years of Quality Assurance (QA) or Quality Control (QC) experience within IVD, medical device, pharmaceutical, or biotechnology environments. Strong working knowledge of ISO 13485, ISO 14971, EU IVDR, and FDA medical device quality regulations. Hands-on experience managing deviations, CAPAs, change controls, nonconformances, and document control within a regulated QMS. Strong SOP development, review, and management experience. Excellent technical writing, documentation, communication, and organizational skills. Ability to manage multiple projects and collaborate with cross-functional teams. Pay Rate: $45/hr on W2

Benefits

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements: Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums. Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided. Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.