Job Description This role is responsible for executing validation and quality activities required for the introduction and delivery of a new Hinge cast product line, as well as supporting EU MDR validation assessment and rationalization. The position operates in a highly regulated medical device manufacturing environment and requires strong expertise in process validation, quality systems, and change control. The successful candidate is a proactive self-starter who collaborates effectively across cross‑functional teams to ensure compliance with global regulatory requirements. 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 Experience in medical device manufacturing or another highly regulated industry. Strong background in process validations, including IQs, OQs, PQs, and TMVs. Demonstrated experience working within regulated quality systems and global compliance frameworks. Proven ability to conduct non-conformance investigations and manage multiple priorities effectively. Experience with change control processes and PLM systems. Strong written and verbal communication skills.