Quality Systems Specialist
usd85.17k - usd93k per yearDanaher
SCIEX, a Danaher operating company, seeks a Quality Systems Specialist to maintain and improve their Quality Management System in compliance with ISO 9001, ISO 13485, and FDA regulations. The role supports audits, CAPA, document control, training, and continuous improvement initiatives across the organization.
Responsibilities
- Support QMS process maintenance and improvement aligned with regulatory and internal requirements
- Administer eQMS activities including document changes, controlled records, training assignments, and procedure revisions
- Guide audit and CAPA owners through investigations, action planning, implementation, and effectiveness verification
- Monitor quality metrics, analyze trends, and escalate compliance risks to QMS leadership
- Support non-product software validation and cross-functional QMS improvement projects
Requirements
- Bachelor's degree in science, engineering, quality assurance, or related field
- Minimum three years of quality assurance or QMS experience in regulated environment (IVDs, clinical, pharmaceuticals)
- Working knowledge of ISO 9001, ISO 13485, and FDA quality-system requirements
- Experience supporting QMS audits, CAPA processes, document control, and quality records
- Proficiency with eQMS applications, procedure writing, and quality-data reporting
Compensation: $85,167–$93,000 base (plus eligible bonus/incentive pay)
Vacancy posted 7 hours ago
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