Quality Analyst
$34,000–$37,000 year
On-siteQuality, Georgia, United States
Job Summary
Coordinate day-to-day tasks and direction for Quality Technicians, providing technical support, mentoring, and oversight of all product and report pre-reviews and releases. Execute product and report releases for processing runs containing non-conformances, lead associated investigations, and manage customer communication. Initiate corrective actions, problem-solving, and continuous improvement activities using statistical techniques to review data and recommend process changes. Perform internal audits at other facilities, manage remediation of observations, and create or revise quality system policies and procedures. Monitor performance metrics and instruct employees in quality principles and valid statistical techniques while collaborating with cross-functional teams. Ensure all external and internal requirements are met according to documented policies, procedures, standards, and regulations. This temporary maternity cover position requires a Bachelor's Degree and 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
Required Qualifications
- Bachelor's Degree
- 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience
- 1-5 years of experience working in an ISO certified environment
- Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra
- Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint
- Ability to work in a fast-paced, regulated environment with strict deadlines
Desired Qualifications
- 1-5 years of experience with medical device or other regulated industries preferred
- Working knowledge of FDA QSR/ EUGMP regulations strongly preferred
- Excellent problem-solving skills
- Focus on identification of potential issues and continuous improvement
- Experience working on cross-functional teams and on own initiative
- Demonstrated excellent organizational, oral and written communications skills
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