This role involves providing full people management responsibility for salaried and hourly Quality team members while driving continuous improvement across the organization
Job Summary
This role involves providing full people management responsibility for salaried and hourly Quality team members while driving continuous improvement across the organization.
The successful candidate will serve as a subject matter expert in domestic and international regulations including FDA QSR and ISO 13485 standards.
Key responsibilities include overseeing Quality System execution, managing change control reviews, and ensuring all launches meet strict regulatory requirements.
Matching Summary
This role involves providing full people management responsibility for salaried and hourly Quality team members while driving continuous improvement across the organization.
Salary
Base: $133,400 - $222,300 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Manage quality engineering team members
Oversee FDA QSR and ISO 13485 compliance
Drive continuous improvement methodologies
Handle complaint handling and CAPA reviews
Support new product development lifecycle
Nice-to-have
Strong leadership and interpersonal skills
Experience with Notified Body inspections
Cross-functional partnership capabilities
Talent development planning expertise
Key Requirements
Bachelor's degree in Engineering related discipline
Minimum 6 years of engineering experience in regulated environment
Working knowledge of ISO 9001, ISO 13485, or FDA 21 CFR Part 820
1+ years of demonstrated experience leading high-performing teams