Warehouse Quality Specialist
$86,600–$119,200 year
On-siteIrvine, California, United States
Job Summary
Manage ongoing collection, analysis, and communication of QMS performance data while serving as the Quality Management Representative for the Quality Management System. Approve corrections and containments for identified product issues, coordinate internal audits, and act as the primary contact for external inspections. Authorize product and process changes with moderate to high complexity, promote risk-based approaches, and lead the development of Quality Management System programs compliant with regulatory requirements. Based in Irvine, California, this role requires a Bachelor's degree and 3-5 years of experience in a regulated distribution environment.
Required Qualifications
- Bachelor's degree in Engineering, Biology, Chemistry, or related discipline
- Minimum 3-5 years relevant experience, or equivalent combination of education and experience, relevant medical device industry and quality systems experience in a regulated distribution/warehouse environment (Good Distribution Practices (GDP), ISO9001 and/or ISO 13485)
- Minimum 2 years experience working with ERP (enterprise resource planning) systems such as SAP or Oracle
- Experience with the development and implemention of QMS processes, procedures, and activities
- Experience supervising/managing quality systems in a regulated environment
- Communication, public-speaking, decision-making, word processor, spreadsheet, and negotiation skils
- Project management, multitasking, organizational, interpersonal, and leadership skills a must
- Ability to drive continuous improvement
- Location: This position must be based in Irvine, California and requires the employee to be located within commuting distance of the office
Desired Qualifications
- Certification as an ISO9001 and/or ISO13485 lead auditor a plus
- Audit experience (i.e. Internal, External, 3rd party)
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