Quality Systems Specialist-Irvine, CA

At Fisher & Paykel Healthcare, our dedication unites us in a shared mission to improve patient care and outcomes through world‑leading healthcare solutions. We call this commitment Care by Design.

Our journey began in New Zealand over five decades ago when a visionary doctor and two ingenious engineers pioneered a new approach to respiratory health.

Today, we are a leading designer, manufacturer, and marketer of products and systems for acute and chronic respiratory care, anesthesia, and the treatment of obstructive sleep apnea. Our innovative products touch the lives of millions of patients annually while operating in over 120 countries worldwide.

We seek individuals who are passionate about having a lasting, positive impact. We value individuals who prioritize enduring relationships and creative thinking and who are driven to make a difference.

In return, we will support your personal and professional growth with our inclusive work environment, built on a foundation of care and collaboration.

Together, we form a team of compassionate individuals dedicated to purposeful work.

Care to join us and make a real impact?

The Quality Systems Specialist will administrate, coordinate, and execute tasks and activities that contribute to the maintenance and continuous improvement of the North American Quality Management System to ensure compliance to internal and external regulatory requirements.

• 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, elevate equipment calibration non‑conformances, ensure accurate information on the equipment calibration system, and maintain 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) remain within established specifications, otherwise take actions as per documented requirements }. (Fixed native placeholder).
• Collect, analyze, and report dataφαρ to identify trends.
• Support internal and external audit activities.
• May perform other duties as required.

• Bachelor's degree in relevant field a plus but not required.
• númerico technical or associate degree in relevant field.
  
  Technical writing skills preferred.
• Proficient in using Microsoft Office.
• Experience with data analysis tools desired.
• Communication skills with ability to collaborate and deliver presentations across functional teams and facilities.
• Knowledge and/or working experience in a highly regulated environment preferred.
• 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.
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The anticipated salary range for candidates working in Irvine, CA, is $70,000 to $80,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Fisher & Paykel Healthcare is a multi‑state employer, and this salary range may not reflect positions that work in other states.

In return, we will offer you an opportunity to work as part of a dedicated and energetic team at a company with a fantastic culture of commitment to our employees and customers. You'll have an opportunity to participate in a comprehensive benefits package that offers medical,…