North America CQSS QMS Analyst
$79,000–$142,000 year
On-site · Mooresville, Indiana, United States
Job Summary
Support and drive the effectiveness and continuous improvement of the Quality Management System (QMS) across the North America region, ensuring compliance with applicable quality system regulations and internal standards. Key activities include maintaining and improving QMS processes (document control, change management, CAPA, internal audits, management reviews), analyzing quality data and metrics for leadership reporting, participating in internal, supplier, and regulatory audits, ensuring timely closure of audit findings, contributing to training materials and training compliance, and collaborating with cross-functional teams to apply QMS requirements consistently. English proficiency and up to ~10% travel are required. Preferred familiarity with eQMS tools, CAPA, change control, and regulatory inspections in a medical device context.
Required Qualifications
- Bachelor’s degree required, preferably in Engineering, Life Sciences, Quality, or a related technical discipline
- Approximately 2–4 years of experience in Quality, Compliance, or Quality Systems within a regulated environment (medical device, pharmaceutical, or similar)
- Working knowledge of Quality Management Systems and applicable regulations and standards (e.g., FDA QSR, ISO 13485)
- Experience supporting audits, inspections, or quality system assessments
- Ability to manage multiple priorities and work effectively in a cross-functional environment
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