This role will conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System
Job Summary
This role will conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System.
The company offers career development with an international company, free medical coverage, an excellent retirement savings plan, and tuition reimbursement.
Abbott is recognized as a great place to work in dozens of countries and named one of the most admired companies in the world by Fortune.
Matching Summary
This role will conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System.
Salary
Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
internal quality audits
FDA, ISO, MDD, CDR, MHLW regulations
corrective action tracking
international standards interpretation
QMS and EMS compliance audits
compliance team liaison
Nice-to-have
cross-division business unit model
highly matrixed environment
fast-paced, changing environment
collaboration with all levels
Key Requirements
Bachelor’s degree in scientific, engineering, or quality-related field
Min 10 years of medical device industry experience
Min 8 years auditing per ISO and/or FDA standards
Lead Auditor Certification for ISO 13485 or 9001:2000