Job description

Masimo Benefits:

• Annual bonus eligibility
• 3 weeks’ vacation
• Paid sick time
• Comprehensive medical/dental/vision coverage plans
• Restricted Stock Units (RSUs)
• 401(k) with employer match
• Relocation assistance
• Employee Assistance Program (EAP) resources
• Life Insurance and Disability
• Employee Referral Bonus Program
• Wellness Incentive Program
• Restaurant quality meals served by Masimo Technology Café
• On-site Wellness Center
• On-site recreational activities: sand volleyball, badminton, ping-pong, and dedicated sports groups such as basketball, soccer, Ultimate Frisbee, running, and more

Qualifications:
Masimo is a federal contractor and therefore subject to the requirements outlined in Executive Order 14042. Consistent with the Executive Order, employees will be required to submit proof of vaccination prior to their start date as a condition of employment. Masimo is an equal opportunity employer and reasonable accommodation requests will be considered.

• Bachelor’s degree is required (preferably in a Science related discipline), or an equivalent combination of education and related experience.
• 5 years’ experience in regulated industry.
• Excellent communication skills and the ability to express ideas both orally and in written form.

• Well organized and accustomed to maintaining excellent records.
• Ability to work with minimal supervision.
• Advanced computer skills including: Word, Excel, PowerPoint and management of spreadsheets and generating reports.
• Apply effective time management, critical thinking, problem solving and collaborative approaches to improving internal audit program.
• Ability to analyze situations thoroughly, identify potential problems, find and implement effective solutions.
• Ability to travel approx. 20% per year.

Preferred:

• 5 years of direct quality experience, preferably in a medical device manufacturing environment.
• Experience with GCP.
• Expertise in FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), MDD (European) requirements; Knowledge of Brazil GMP.
• Experience in Regulated environment such as ISO 9000 series, related standards like ISO 13485 and Automotive Industries.
• Certification as a quality auditor from ASQ, RAPS, ISO or equivalent.

Responsibilities:

• Maintain and support Internal Audit process.
• Adhere to approved audit plans.
• Prepare audit agenda including: objective, scope and criteria.
• Document findings and create audit records.
• Work with departments/auditees to address identified issues, provide recommendations and facilitate the corrective action process.
• Communicate action items and escalate issues to management.
• Ensure audit findings are addressed in a timely manner.
• Verify the effectiveness of corrective actions taken as a result of the audit.
• Prepare audit reports and maintain audit files.
• Assist with trend analyses related to audits (e.g. types/number of observations).
• Follow up with Process Owners to ensure actions are being completed per defined requirements.
• Identify and communicate opportunities to improve the quality management system.
• Research applicable regulations and standards to ensure the Company’s ongoing compliance.
• Other duties or special projects as assigned.

Job Summary:

• The Internal Auditor, Quality is responsible for the execution of Internal Audit activities and assisting with the administration of the Internal Audit process in accordance with Company procedures. This position will interface with individuals at all levels of the organization to conduct audits at specified intervals and report audit findings. This position will facilitate and monitor the life cycle of audit findings until completion.

About Masimo:
For over thirty years, Masimo has been expanding the boundaries of noninvasive monitoring to improve patient outcomes and reduce the cost of care. Today, Masimo delivers a portfolio of hospital-trusted monitoring solutions to help increase patient safety, health, and wellness in the hospital and at home. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others.

Location:

• Irvine, California

Physical Requirements:

• This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Job Type: Full-time

Schedule:

• Monday to Friday

Application Question(s):

• Do you have experience working in a regulated industry/environment? (e.g. automotive, medical device, aerospace)

Work Location: In person

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