Quality Systems Engineer II
HybridKennesaw, Georgia, United States
Job Summary
Oversee the implementation and maintenance of the Quality Management System, including administering the electronic quality management system and performing gap analyses. Coordinate corrective and preventive actions using root cause analysis tools, monitor nonconformances, and ensure timely closure of audit findings. Support internal and external Quality System audits, manage the corporate change control process, and assist with management reviews and training for QSE I. Maintain Quality System Procedures and report data on Key Performance Indicators to management. Contribute to continuous improvement activities and assist with the development and support of eQMS software systems.
Required Qualifications
- Bachelor's degree in a technical / scientific related field, or an equivalent field of study, or the equivalent years' work experience.
- 3+ years of experience in quality engineering, quality assurance, or a similar role.
- Experience with electronic quality management systems and using QA software tools.
- Strong analytical and problem-solving skills.
- Excellent verbal and written communication skills, including business writing.
- Working knowledge of current Good Manufacturing Practices, Good Tissue Practices, Tissue Banking Regulations, Quality System Regulations, and ISO Standards.
Desired Qualifications
- ASQ CQA/CQE/LSS and/or AATB CTBS or other auditing certification preferred.
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