Sr QA Specialist - Supplier QA

Job Description

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 suppliers-especially 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.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy : https : / / insightglobal.com / workforce-privacy-policy / .

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