Job Description Insight Global is looking for a Quality and Compliance Professional to support a medical device and technology company in Irvine, CA. This person will be supporting regulatory quality systems compliance activities involving a large acquisition. We are looking for an experienced quality leader who will be responsible for driving quality management systems implementation, continuous improvement initiatives, and cross-functional projects that support regulatory compliance and business objectives. This person needs to be an SME in regulatory compliance, quality management systems, and quality tools. They will be providing guidance, risk-based decision making, and project leadership across complex initiatives. This is not a people-manager role, but this person will be responsible for managing that requirements are met and auditing how they are met. 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.

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• Bachelor's degree in Engineering, Life Sciences, Quality, or related field.
• 6+ years of experience in Medical Device, Pharmaceutical, Biotech, or regulated healthcare industries.
• Demonstrated experience leading complex quality and regulatory compliance initiatives.
• Experience supporting regulatory inspections, internal audits, and quality management system activities.

Experience working in cross-functional teams and managing multiple projects simultaneously. ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent Project Management Professional (PMP) certification or equivalent project management training Lean Six Sigma Green Belt or Black Belt Internal Auditor and/or Lead Auditor training Quality Management System Requirements training (ISO 13485) Risk Management training (ISO 14971)