The primary purpose of this role is to be a functional leader within the quality organization coordinating team deliverables and ensuring quality requirements are met
Job Summary
The primary purpose of this role is to be a functional leader within the quality organization coordinating team deliverables and ensuring quality requirements are met.
You will supervise, coach, and direct a team of quality professionals while driving process improvements using a risk-based approach.
Success requires adherence to FDA regulations, ISO standards, and fostering a culture where every associate owns quality.
Matching Summary
The primary purpose of this role is to be a functional leader within the quality organization coordinating team deliverables and ensuring quality requirements are met.
Skills & Requirements
Must-have
Bachelor's degree in engineering
3 years of quality experience
ISO 13485 and ISO 9001 knowledge
FDA 21 CFR 820 regulations
CAPA and root cause analysis
Team leadership and coaching
Nice-to-have
Bias for action and decision making
Fast-paced complex environment
Cross-functional consensus building
Continuous improvement ideation
Diverse and inclusive work environment
Key Requirements
Bachelor's degree in engineering or related technical field
Minimum 3 years of relevant experience
Knowledge of EU MDR and Good Manufacturing Practices