Base salary: not specified; bonus/equity: cash-bas...
Bachelor's degree in engineering
3 years of quality experience
Iso 13485 and fda regulations knowledge
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 adherence to Quality Management Systems (QMS), Environmental Management Systems (EMS), and FDA regulations while driving process improvements to enable accurate and efficient department execution.
The company offers a comprehensive benefits package including medical, dental, vision, disability, life insurance, and immediate eligibility for 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; Bonus/Equity: Cash-based incentive program available; Benefits: Comprehensive package including medical, dental, vision, 401(k) match, and paid time off
Skills & Requirements
Must-have
Bachelor's degree in engineering
3 years of quality experience
ISO 13485 and FDA regulations knowledge
QMS and EMS implementation
Root cause analysis and CAPA management
Nice-to-have
Strong leadership and coaching skills
Bias for action and problem solving
Experience with continuous improvement methodologies
Ability to work in fast-paced environment
Cross-functional collaboration expertise
Key Requirements
Bachelor's degree in engineering or related technical field
Minimum 3 years of relevant experience
Knowledge of EU MDR, ISO 13485, ISO 9001, 21CFR820
Auditing experience required
US citizenship not explicitly stated but US applicants mentioned