Bachelor's degree in engineering or technical field
3 years of quality management experience
Knowledge of iso 13485 and fda regulations
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 achieved
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 achieved.
You will supervise, coach, and direct a team of quality professionals while driving process improvements using a risk-based approach to maintain compliance with the Quality Management System.
Success in this position requires embedding a culture where every associate owns quality, ensuring adherence to strict regulatory standards like EU MDR and Good Manufacturing Practices.
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 achieved.
Skills & Requirements
Must-have
Bachelor's degree in engineering or technical field
3 years of quality management experience
Knowledge of ISO 13485 and FDA regulations
Experience with CAPA and root cause analysis
Leadership of quality engineers and technicians
Nice-to-have
Strong bias for action and decision making
Ability to work in fast-paced environment
Commitment to diversity and inclusion culture
Experience with 5S and visual controls
Effective cross-functional communication skills
Key Requirements
Minimum Bachelor's degree in engineering or related technical field
Minimum 3 years of relevant experience
Specialized knowledge of EU MDR, ISO 13485, ISO 9001, and 21CFR820
Auditing experience required
U.S. citizenship not explicitly required but US applicants mentioned