As a Quality Manager you will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations
Job Summary
As a Quality Manager you will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.
Develops and executes the required strategies and plans to improve product and process quality to deliver planned business results and assure compliance with FDA and ISO regulations and any country specific regulation where product is distributed.
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.
Matching Summary
As a Quality Manager you will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.
Skills & Requirements
Must-have
FDA and ISO regulations
US 21 CFR 820 (QSR)
ISO 13485
Process Control & Monitoring
Nonconformance and CAPA systems
Quality Metrics
New Product Introductions
Nice-to-have
Six Sigma
Lean
Opex
disciplined problem solving
organizational influence
Key Requirements
7 years of experience in a regulated industry
5 years in Quality roles
FDA Class II or Class III medical device experience
Bachelor's degree in Engineering, Science or Technical Field, or Business Administration