In this role, you will support the CAPA process, change control, and internal/external audit support activities. You will implement, maintain, and improve the Quality Management System (QMS) at the designated sites, ensuring compliance with corporate processes and industry regulations. This position is crucial for defining process improvement directions and ensuring audit readiness.
Skills:
- Strong knowledge of Quality Management Systems
- Proficiency in audit processes and compliance assessments
- Experience with CAPA management and root cause analysis
- Familiarity with data analytics tools (Power BI, Excel, etc.)
- Excellent written and verbal communication skills
- Strong critical thinking and analytical skills
Responsibilities:
- Create and revise standard operating procedures as needed
- Perform ongoing gap analysis against requirements and regulations
- Ensure compliance with QMS and update Quality Metrics
- Assist in preparations for internal and external audits
- Lead or participate in audits as necessary
- Evaluate, trend, and triage issues for CAPA management
- Leverage analytical tools to deliver solutions for business problems
Qualifications:
- Bachelor’s Degree and 7+ years of Quality Engineering and/or regulated industry experience OR Advanced Degree and 5+ years of experience in Quality Engineering and/or regulated industry
- Experience with Management Review, Change Control, and Audit processes
- Familiarity with regulatory standards (21CFR 820, ISO 13485, etc.)
- Previous experience with effective root cause investigation and corrective action planning
