Sr Internal Auditor, Quality

Masimo•Irvine, CA

4h•$80,000 - $110,000•Onsite

About The Position

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.

Requirements

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
Bachelor’s Degree is required (preferably in a Science related discipline), or an equivalent combination of education and related experience.

Nice To Haves

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

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

Benefits

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
cafe
This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.