Sr Internal Auditor, Quality at Masimo

Irvine, California, United States -

Full Time

Start Date

Immediate

Expiry Date

27 May, 26

Salary

110000.0

Posted On

26 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Internal Auditing, Quality Compliance, Regulatory Requirements, GCP Audits, FDA 21CFR Part 820, ISO 13485, CMDR, EU MDR/MDD, Time Management, Critical Thinking, Problem Solving, Collaboration, Data Analysis, Report Generation, Stakeholder Management, Risk Assessment

Industry

Medical Equipment Manufacturing

Description

Job Summary The Sr Internal Auditor Quality Independently leads Masimo’s Global Audits in the planning, conducting, and reporting of internal audit results. The Sr Internal Auditor is responsible for the execution of audits to assure adherence to corporate policies, internal standards/requirements, and compliance with applicable regulatory requirements. Ensures the relevant standards, procedures, and audit plans are understood by the organization and applied during the audit activities. Analyze and review procedures, and data to ensure appropriate sampling. This position will facilitate and monitor with minimal oversight, the life-cycle of audit findings until completion. Duties & Responsibilities Responsible for executing Corporate Quality Compliance Audits Leads Corporate Quality Compliance Audits to achieve Corporate Audit Schedule Assesses the state of compliance with corresponding regulations and leads the assessment of actions to correct deficiencies. Manage the completion of the assigned audit results by collaborating with stakeholders Presents audit results concisely Conducts GCP audits (Internal and External Labs) to ensure adherence to Masimo corporate procedures and regulatory requirements Interacts with other functional leaders to ensure compliance with Masimo’s policies, standards, and external regulatory requirements Provides leadership towards escalating compliance issues as identified during audits Serves as a subject matter expert for regulated requirements and for Continual improvement initiatives Provides backroom support for external audits and inspections Provide and maintain audit and inspection quality metrics 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 Minimum & Preferred Qualifications and Experience: Minimum Qualifications 5 + years of experience in regulated industry Expertise in FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), EU MDR/MDD (European) requirements; knowledge of Brazil GMP; ISO 14155, Good Clinical Practice (GCP) Mentor and develop auditees and other quality compliance personnel 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 ~20%/year Preferred Qualifications Ten years of direct Quality experience, preferably in a medical device manufacturing environment or regulated industries Experience with GCP is preferred Certification as a quality auditor from ASQ, RAPS, ISO or equivalent Education Bachelor’s Degree is required (preferably in a Science related discipline), or an equivalent combination of education and related experience. Compensation The anticipated salary range for this position is $80K-$110K plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance. Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness center, fitness center, and cafe . All benefits are subject to eligibility requirements. Physical requirements/Work Environment 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.

Responsibilities

The Senior Internal Auditor Quality independently leads global audits, focusing on planning, conducting, and reporting internal audit results to ensure adherence to corporate policies and regulatory compliance. This role involves executing Corporate Quality Compliance Audits, assessing compliance states, managing audit findings to completion, and presenting results concisely to stakeholders.