"Alerted.org

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) .

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

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].