Job Description:
The Supplier Quality Engineer will play a critical role in executing supplier-related quality activities associated with the transfer of manufacturing operations between sites. This individual will ensure supplier qualification, process validation, and product quality continuity are maintained in alignment with FDA, ISO 13485, and internal quality standards. The role requires cross-functional collaboration with Supplier Quality, Manufacturing Engineering, Regulatory Affairs, and Operations teams to mitigate risk and ensure uninterrupted supply of compliant medical devices throughout the transfer lifecycle.
Skills and Requirements:
Bachelor’s degree in Engineering or a related technical field (e.g., Mechanical, Biomedical, Industrial).
4+ years of experience in Supplier Quality, Quality Engineering, or Manufacturing Engineering within the medical device or regulated industry.
Experience supporting manufacturing transfers, site transfers, or product/process transfers.
Strong knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and GMP requirements.
Hands-on experience with: Supplier qualification and auditing Process validation (IQ/OQ/PQ)CAPA, NCR, and root cause analysis methodologies Risk management (ISO 14971 preferred) Familiarity with PPAP, FMEA, control plans, and statistical analysis tools.
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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 the recruiting process, please send a request to HR@insightglobal.com.
