• Quality System Specialist

    Insight Global (Irvine, CA)


    Job Description

    Insight Global is looking for a quality system specialist for one of our medical device companies in the Irvine California area. This person will be responsible for maintaining the manufacturing department and keeping them held to standards and regulations. Ensuring that all accessories and devices comply with iso 1345. They will be involved in audits and would require strong auditing skills. This role also will involve cradle to grave in CAPA. They are also in the process of spinning up an electronic compliance management system and would be a large part of documentation in that.

     

    We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

     

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    Skills and Requirements

    5 years of experience as a Quality Systems Specialist, Quality Control Specialist, Document Controls Specialist; in a manufacturing environment,

     

    Needs to come from Medical Device

     

    Full-cycle CAPA experience

     

    Strong knowledge on ISO-1345

     

    Experience in internal and/or external auditing to Quality System requirements

     

    Experience from Class II or Class III

    Experience with metric reporting Experience with supplier qualities null

    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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. 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 [email protected].