This role provides leadership for the quality engineering department supporting commercial products and new product development within Abbott's Electrophysiology business
Job Summary
This role provides leadership for the quality engineering department supporting commercial products and new product development within Abbott's Electrophysiology business.
The position requires developing goals, objectives, procedures, and systems that align with company mission and FDA/ISO regulations to ensure product quality.
Employees enjoy access to free medical coverage, a high employer contribution retirement plan, tuition reimbursement, and an affordable path to a bachelor's degree.
Matching Summary
This role provides leadership for the quality engineering department supporting commercial products and new product development within Abbott's Electrophysiology business.
Salary
Base: $129,300.00 – $258,700.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
FDA and ISO regulatory compliance
GMP GLP GCP experience in regulated environment
10 years related work experience minimum
5 years people management experience required
Medical device manufacturing background
Nice-to-have
MBA preferred qualification
TUV regulations familiarity
Class III or II medical device leadership
ISO 9001 and ISO 13485 knowledge
Entrepreneurial environment creation
Key Requirements
Bachelor's Degree in related field or equivalent
Minimum 10 years of related work experience
Minimum 5 years of people management experience
Extensive domestic and international regulatory experience
Experience working in GMP, GLP, and GCP environments