Base salary not specified; cash-based incentive pr...
Bachelor's degree in engineering or related technical field
3 years of experience in quality management
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 and providing daily direction to quality professionals
Job Summary
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables and providing daily direction to quality professionals.
You will ensure compliance with Quality Management Systems, Environmental Management Systems, and FDA regulations while driving process improvements to enable accurate and efficient department execution.
The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching contributions.
Matching Summary
The primary purpose of this role is to be a functional leader within the quality organization, coordinating team deliverables and providing daily direction to quality professionals.
Salary
Base salary not specified; Cash-based incentive program available; Comprehensive benefits package including medical, dental, vision, 401(k) match
Skills & Requirements
Must-have
Bachelor's degree in engineering or related technical field
3 years of experience in quality management
Knowledge of ISO 13485 and FDA regulations
Experience with Quality Management Systems (QMS)
Ability to lead and develop quality teams
Nice-to-have
Strong bias for action and problem-solving skills
Experience with root cause analysis and CAPA
Excellent written and oral communication skills
Familiarity with Lean Manufacturing principles
Ability to work in a fast-paced environment
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, 21CFR820