Sr QA Specialist

Job Description We are seeking a Senior Quality Specialist to be a key member of the IVD Quality team, leading the development and implementation of a Quality Management System (QMS) from the ground up. This role is ideal for someone who thrives in a dynamic environment and is passionate about building quality infrastructure that supports in vitro diagnostic (IVD) product development, design transfer, and post-market activities. This person will have ownership of defining, designing, and configuring quality processes and procedures in alignment with ISO 13485, IVDR, and other global standards. They will collaborate cross-functionally to gain buy-in, write documentation, and implement workflows in an electronic QMS platform. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements u2022 Bacheloru2019s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field u2022 5+ years of hands-on quality assurance experience in the medical device or IVD industry u2022 In-depth knowledge of ISO 13485:2016, IVDR (EU 2017/746), and ISO 14971:2019 risk management u2022 Experience implementing and operating a QMS compliant with ISO 13485 u2022 Strong background in design control, risk management, verification & validation, CAPA, change control, complaint handling, and supplier quality u2022 Experience conducting internal audits and supporting external audits (e.g., ISO, notified body, regulatory inspections) u2022 Excellent written and verbal communication skills, with the ability to author clear SOPs and technical documentation u2022 Strong organizational skills and ability to manage and document multiple projects in a fast-paced environment u2022 ISO 13485 Lead Auditor certification or equivalent u2022 Experience with eQMS platforms and electronic workflow configuration u2022 Familiarity with building QMS infrastructure from the ground up u2022 Experience collaborating with international teams, especially in France u2022 Ability to lead CAPA investigations and ensure timely resolution u2022 Experience supporting product design transfer to CMOs u2022 Background in complaint handling and post-market surveillance (PMS)

Created: 2025-10-13