The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables to ensure manufacturing site 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 to ensure manufacturing site quality requirements are met.
You will supervise, coach, and direct a team of quality professionals while embedding a culture where every associate owns quality and adheres to the Quality Management System.
Success in this position requires specialized knowledge of quality system regulations including ISO 13485, ISO 9001, and Good Manufacturing Practices alongside auditing experience.
Matching Summary
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables to ensure manufacturing site 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 regulations 21CFR820 expertise
Team supervision and coaching skills
CAPA and root cause analysis
Nice-to-have
Bias for action and decision making
Experience with EU MDR standards
Strong cross-functional collaboration
Commitment to continuous improvement
Ability to work in fast-paced environment
Key Requirements
Minimum Bachelor's degree in engineering or related technical field