Quality Systems Engineer
On-siteAuburn Hills, Michigan, United States
Job Summary
Manage the site's CAPA system and auditing tool, including training and technical support for local staff. Monitor CAPA progress proactively to ensure timely implementation. Lead cross-functional teams in problem-solving activities and analyze the site's Quality System for compliance with quality and regulatory requirements. Provide technical guidance on complex issues, interpret standards, and perform independent internal audits while supporting external and customer audits. Maintain site-level quality system policies, procedures, and work instructions, and provide Quality Management with key plant metrics updates. Assist in developing metrics for the Quality Systems department and support software and systems validation plan requirements. Work safely and comply with Environmental Health and Safety standards.
Required Qualifications
- Bachelor's degree in Business Administration, Engineering or other similar related disciplines
- At least 2 years of experience working with manufacturing quality systems or regulatory and compliance
- A minimum of 1 year of experience of actively participating in internal and external audits
- Certified internal auditor or advanced knowledge of Regulatory and ISO standards
- Strong communication skills both verbal and written
- Strong working knowledge of Root Cause Analysis
- Ability and experience supporting internal and external audits
- High-level computer skills (Windows and Microsoft Office applications)
Desired Qualifications
- Project management, statistical analysis, and problem-solving skills
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