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[QUALITY ASSURANCE] Manager, Quality System Compliance
at Masimo Corporation
Job Code Posting:
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 20 years, innovation has been and will continue to be our passion.
To learn more about us, please visit: www.masimo.com
The Manager, Quality System Compliance will provide leadership in the implementation, maintenance, and improvement of company-wide quality management systems, procedures and support processes. Proactively monitors the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards. Ensures processes and tools are established to ensure ongoing compliance with applicable requirements. Manages activities related to Health Hazard Evaluations (HHE) and field actions. Supports external audits by the FDA, the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings. Provides support to internal functions in the application, maintenance and improvement of quality systems and department specific processes. Provides hands on support to international Masimo sites to facilitate the development of quality systems and business processes. Promotes quality achievements and performance improvements throughout the organization.
Duties & Responsibilities
- Is directly responsible for ensuring that Masimo’s quality systems are in compliance with the applicable regulations and national & international quality standards;
- Provides support to internal functions in the application, maintenance and improvement of quality systems, procedures and department specific processes;
- Manages activities related to Health Hazard Evaluations (HHE) and field actions to ensure compliance with applicable regulatory requirements;
- Manages external audits by the FDA, the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings;
- Ensures the coordination between Masimo facilities so changes in the quality management system are implemented with consideration to compliance and changing business needs;
- Supports external customers to provide documentation in support of requests to provide evidence of implementation of a certified quality system;
- Prepares performance reports and metrics for the Quality Management System and assist other departments in establishing reports to support evaluation and improvements of ongoing business activities;
- Reviews quality system processes and ensures data integrity within Agile;
- Provides hands-on ownership for quality systems improvement projects to ensure various elements of the quality system continue to support changing business needs and goals;
- Ensures efficient and effective processes and tools are established for compliance with QSR and ISO standards requirements;
- Other projects as assigned by the management.
- 7 to 10 years of experience in a FDA regulated industry;
- 2 years of experience in a management role with demonstrated leadership skills;
- Direct experience with FDA QSRs, ISO 13485, MDD 93/42/EEC, ISO 14971, Canada Medical Device Regulations, J-Pal and Brazil GMP;
- Direct experience in health hazard evaluation/analysis, product recalls and other field actions;
- Direct experience in quality system audits;
- Strong communication skills;
- Excellent documentation skills;
- Flexibility and adaptability;
- Fast learner;
- Independent worker;
- Experience in medical device manufacturing environment;
- Prior experience with Agile and Oracle systems is preferred;
- Project management experience is preferred.
B.S. in Engineering, Science or an equivalent combination of education and experience is required. B.S. or higher degree in Engineering is preferred.
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.
We are proud to offer if eligible a highly competitive compensation plan with an excellent benefits package including 3 weeks vacation, stock options, 401k match, medical, dental, vision plans and much more!
Masimo is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state or local law.
***NO AGENCIES PLEASE*** Thank you!