The Manager, Internal Audit is responsible for the management of the internal quality auditing process and assessment of Masimo’s activities to confirm compliance with Masimo’s quality system.
Duties & Responsibilities
Supervise the day to day internal auditing functions;
Prepare auditing plans and materials, schedule and conduct auditing of the quality system;
Ensure auditing system and database is managed and up to date;
Perform internal quality audits and global Corporate quality audits of foreign and domestic facilities:
Create annual internal quality systems auditing plan.
Plan, schedule and execute audits.
Maintain audit files.
Work with departments/auditees to develop appropriate actions, provide recommendations and oversee the corrective action process to remediate any deficiencies.
Communication on action item status and escalate issues to management for awareness.
Researches applicable regulations and standards and define improvements to the quality system to ensure the Company’s ongoing compliance with applicable requirements.
Generate and maintain trend analyses related to audits (e.g., types/number of observations).
Ensure audit findings are addressed in accordance with documented requirements.
Coordinate, host and ensure proper follow up of external audits, as assigned (e.g., Customer Audits and ISO audits, etc.);
Monitor trends in areas of responsibility and recommend additional actions required to address systemic issues;
Administrative activities related to the management of the internal audit function;
Coordinate and review the work of team members reporting to this position; coordinate work schedules; assist management in defining requirements for performance of the group; monitor and report on performance against defined requirements; identify training and development opportunities for staff; provide input on hiring, promotion, and termination decisions; provide input on staff annual performance appraisals and salary increase decisions; provide technical guidance and/or subject matter expertise for staff;
Perform special projects as requested;
Five years of experience conducting audits in the medical device industry;
Prior supervisory experience;
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;
Excellent communication skills and the ability to express ideas both orally and in writing effectively with all levels and functions of the organization;
Well organized and accustomed to maintaining excellent records;
A “hands on” individual, who is capable and dedicated to getting the job done with minimal support and direction;
Basic 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 training program and corrective action plans; analyze situations thoroughly, identify potential problems, find and implement effective solutions;
Prepare and present written correspondence, reports, and materials in a clear, correct and comprehensible manner;
Must be able to travel up to 20%;
Five years of direct quality experience, preferably in a medical device manufacturing environment;
Certification as a quality auditor from ASQ, RAPS, ISO or equivalent;
Bachelor’s Degree in Sciences required. An equivalent combination of education and related experience may be considered in lieu of a Bachelor’s degree.
Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 25 years, innovation has been and will continue to be our passion.
To learn more about us, please visit: www.masimo.com