Fisher & Paykel Healthcare · 22 hours ago
Quality Systems Specialist
Irvine, CA
Full-time
Onsite
New Grad, Entry Level
$70K/yr - $80K/yrFisher & Paykel Healthcare is dedicated to improving patient care through innovative healthcare solutions. The Quality Systems Specialist will manage and enhance the North American Quality Management System to ensure compliance with regulatory requirements and internal standards.
Health CareManufacturingMedical Device
No H1B
U.S. Citizen Only
Responsibilities
Administrate the training process to ensure training requirements are communicated to all FPH NA employees, monitoring, and reporting training status, and maintaining training records as per applicable requirements
Administrate the equipment calibration process to support the on-time equipment calibration, coordinate logistics to execute external equipment calibrations, escalate equipment calibration non-conformances, ensures accurate information on the equipment calibration system, and maintaining equipment calibration records as per applicable requirements
Administrate the Maintenance Connection system to manage equipment in FPH North America
Administrate the Document Control process and ETQ system to ensure compliance to the change control and change management process
Coordinate the non-conformance process to support the on-time containment and disposition of non-conformances (Non-Conformance Reports and Hold Orders)
Monitor the environment control system to ensure controlled conditions (Temperature and % of Relative Humidity) remains within established specifications, otherwise take actions as per documented requirements
Collect, analyze, and report data to identify trends
Participate in continuous improvement initiatives
Support internal and external audit activities
May perform other duties as required
Qualification
Required
Technical or associate degree in relevant field
Proficient in using Microsoft Office
Communication skills with ability to collaborate and deliver presentations across functional teams and facilities
Effective interpersonal skills
Advanced written and verbal communication skills
Excellent attention to detail
Ability to learn and develop expert knowledge about F&P products, processes, and systems
Preferred
Bachelor's degree in relevant field a plus but not required
Technical writing skills preferred
Experience with data analysis tools desired
Knowledge and/or working experience in a highly regulated environment preferred
Benefits
Medical
Dental
Vision
Life insurance
Paid parental leave
401k
Employee stock purchase plan
Company
Fisher & Paykel Healthcare
Fisher & Paykel Healthcare is a manufacturer, designer and marketer of products.
Founded in 1971
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$0.31MKey Investors
Callaghan Innovation
2024-07-22Grant· $0.07M
2023-08-21Grant· $0.06M
2022-09-05Grant· $0.06M
Leadership Team
Dana Thomas
Clinical Market Insights and Analytics Manager
Recent News
Wanganui Chronicle
2025-12-22
Wanganui Chronicle
2025-12-05
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