Supplier Quality Engineer

Masimo - Irvine, CA (30+ days ago)3.4

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:

Job Summary

Supplier Quality Engineer is responsible for all aspects of supplier quality management. Responsible for the qualification of suppliers, for ongoing monitoring of suppliers, for supplier development activities, for all supplier corrective action activities, including updating supplier corrective action database, following up and closing corrective actions and assisting in the maintenance of the supplier files. Responsible for conducting supplier qualification and surveillance audits and completing reports and following up on any related activities.

Duties & Responsibilities

Perform various types of audits (quality system, process and product audits)
Ability to perform reviews with suppliers to determine manufacturability of components.
Create supplier performance metrics and report on performance to suppliers and management.
Work as liaison between suppliers and Masimo to ensure highest level of product quality and supplier performance.
Disposition nonconforming materials and initiate follow up activities to ensure proper corrective action and preclude recurrence of rejections.
Work with various engineering disciplines to resolve issues related to supplier quality.
Work with incoming inspection to ensure proper part surveillance.
Review and approve first articles on custom fabricated components.
Ensure alignment of supplier quality metrics with business objectives.

Skills required:
Strong problem solving ability
Strong Analytical Skills
Strong Communication skills and Documentation skills
Project Management
Flexibility and adaptability
Ability to work with minimal guidance from direct supervisor.
Minimum Qualifications

Three to five years of experience in supplier management, preferably in the medical device industry (note: Supplier management experience in a highly controlled or regulated industry may be considered);
Auditing experience and training (ASQ-Certified Quality Auditor and or Lead Auditor Training for ISO
Familiarity with Quality Standards (ISO 13485, ISO 9001, FDA QSR, etc.)
Ability to travel (domestic & international) up to 25% of the time;
Strong problem solving ability;
Strong Analytical Skills;
Strong Communication skills;
Excellent Documentation skills;
Project Management;
Flexibility and adaptability;
Ability to work with minimal guidance from direct supervisor;
Preferred Qualifications

ASQ-Certified Quality Engineer;

Bachelor of Science degree, preferably in a technical discipline is required.

Physical requirements/Work Environment

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. Minimum 25% travel is required, along with the ability to travel internationally in order to perform day-to-day supplier assessments and other duties associated with the position. Must also be able to lift 25lbs.

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!