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.
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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
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.