Spec Quality
$67,000–$101,000 year
On-siteChicago, Illinois, United States
Job Summary
Develop and maintain quality documentation and processes for specialized subsections of the Quality Management System, including device master records, customer complaints, and product holds. Collaborate with internal and external groups to solve complex problems while ensuring compliance with FDA, ISO, and internal requirements. Facilitate meetings with global business units to manage project requirements and deadlines, then review all related documentation for completeness and accuracy. Make recommendations based on analysis to improve quality standards and customer experience. Requires a Bachelor's degree, two years of quality experience, and up to 10% travel.
Required Qualifications
- Bachelor's degree in Engineering, Science, Math or other related field
- At least 2 years of experience in Quality
- Experience developing ways of accomplishing goals, with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary
- Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects
- Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook ), with an Intermediate skill in Excel
- Experience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusions
- Working knowledge of government and industry quality assurance standards (e.g. 21 CFR 820, ISO 13485)
- Position requires up to 10% travel
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