Quality Manager (Medical Device) Excellent Benefits, Bonus, and Vacation
This Jobot Job is hosted by: David Pacheco
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Salary: $110,000 – $130,000 per year
A bit about us:
Over 5 decades of experience in Total Plastic Solutions for the Medical, Aerospace, Consumer, Defense, and Electronic/Connector industries! We are growing and looking for people to grow with us!
Why join us?
- Excellent Compensation & Benefits package!
- State of the art facility!
- 401K Match!
- Paid Holidays!
- PTO!
Job Details
Responsible for leadership in the areas of Quality Systems and Regulatory Compliance. Plans, establishes, and coordinates company quality systems to ensure compliance with ISO 13485/ ISO 9001/AS9100 standards, and all regulatory and customer requirements.
- Manages, updates, and maintains the company Quality Management System (QMS).
- Ensures compliance with internal and external ISO 9001 / AS9100 / ISO 13485 policies and requirements.
- Coordinates and ensures compliance with all applicable FDA regulations.
- Manages and approves medical device documentation (DHR) per applicable procedures and standards.
- Measures and monitors Key Performance Indicators as required by QMS.
- Prepares, schedules and documents Management Review Meetings as prescribed in QMS.
- Manage compliance with ITAR regulations as required.
Interested in hearing more? Easy Apply now by clicking the “Apply” button.