Sr QA Specialist - Supplier QA

Senior QA Specialist in Supplier Quality Assurance

We are seeking a Senior QA Specialist in Supplier Quality Assurance who will play a critical role in managing and improving supplier and contract manufacturer (CMO) relationships. This person will lead efforts to qualify, monitor, and reassess suppliersespecially during design transfers and new product introductions. This includes conducting audits, managing non-conformances, and ensuring compliance with FDA, ISO 13485, and EU IVDR standards. You'll collaborate closely with R&D, Supply Chain, and external partners to define supplier selection criteria, establish quality agreements, and oversee technical transfers. This is a full-time hybrid role with an anticipated onsite presence of three days per week and approximately 30% travel, primarily domestic with occasional international visits.

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 HR@insightglobal.com.

Skills and Requirements :

• Bachelor's degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related field
• 5+ years of QA experience in the medical device or IVD industry
• Strong expertise in supplier quality management and CMO oversight
• Deep knowledge of ISO 13485 : 2016, ISO 14971 : 2019, and IVDR (EU 2017 / 746) standards
• Proven experience conducting supplier audits and managing corrective actions
• Experience with design transfer and technical validations
• Ability to manage supplier qualification, monitoring, and reassessment processes
• Excellent communication and documentation skills
• Strong organizational skills and ability to manage multiple projects
• Willingness to travel (~30%) to supplier and CMO sites
• ISO 13485 Lead Auditor certification
• Experience with IVDR compliance
• Familiarity with supplier questionnaires and quality management system evaluations
• Experience supporting FDA and Notified Body audits
• Background in managing supplier change notifications and deviations
• Prior involvement in scaling supplier tiers for new product development