• Associate Director, Design Assurance

    Insight Global (Santa Clarita, CA)


    Job Description

    A client in the medical device space is seeking an Associate Director of Design Quality Assurance to join their Quality organization. The ideal candidate will be an experienced leader with strong fundamentals in design controls and risk management that is able to drive compliance and refine processes for the direct reports in their purview. This Associate Director will oversee 6 DQA Managers sitting in multiple locations and report directly to the divisional Director of Quality. This role is audit-facing and requires strong knowledge of the global regulatory environment and adherence to best practices to stay ahead of the evolving landscape. This is a permanent opportunity based in Valencia, CA and hybrid, three days per week onsite.

     

    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 [email protected] 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 Engineering

    • 5+ years of professional Design Assurance experience

    • 5+ years of professional experience in a leadership role

    • Medical Device industry experience • Advanced Degree in a related Engineering field

    • 10+ years of Medical Device experience

     

    o Exposure to Class III Implantable Medical Devices

    o Exposure to devices with embedded firmware

    • Experience supporting Product Development, Sustaining, CAPA, and Post Market Surveillance