Base: $99,300.00 – $198,700.00; bonus/equity: not ...
Onsite
Fda 21 cfr part 820 compliance
Iso 13485 standard knowledge
Quality management system ownership
Abbott is seeking a Manager of Quality for their Neuromodulation division in Plano, Texas. The role involves overseeing the Quality Management System (QMS) to ensure compliance with FDA regulations and continuous improvement of quality processes
Job Summary
This position serves as the quality system owner responsible for developing and maintaining the Quality Management System to ensure compliance with FDA and ISO standards.
The role involves leading and representing the QMS at internal and external audits, including FDA, ISO, and Notified body inspections.
Abbott offers comprehensive benefits including free medical coverage options, a high employer contribution retirement plan, and tuition reimbursement programs.
Matching Summary
Match Score: 85
Abbott is seeking a Manager of Quality for their Neuromodulation division in Plano, Texas. The role involves overseeing the Quality Management System (QMS) to ensure compliance with FDA regulations and continuous improvement of quality processes.
Salary
Base: $99,300.00 – $198,700.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
FDA 21 CFR Part 820 compliance
ISO 13485 standard knowledge
Quality Management System ownership
CAPA process management
Internal and external audit leadership
Nice-to-have
Cross-functional partnership skills
Continuous improvement initiative drive
Proactive compliance culture promotion
Data-driven decision making
Team development and mentoring
Key Requirements
Bachelor's degree or equivalent experience
5+ years of relevant quality work experience
Experience monitoring exempt and nonexempt staff
Ability to investigate and solve work process problems