Overview
Senior Quality Assurance Engineer Jobs in Irvine, California, USA at MicroPort Endovastec
Sr. Medical Device Quality Assurance Engineer
Micro Port Endovastec US is providing an exciting opportunity for a talented Sr. Quality Engineer to join a fast-growing team in Irvine in the field of aortic and peripheral arterial interventional devices. Micro Port Endovastec US is a subsidiary of Shanghai Micro Port Endovastec Inc., a global market leader in treatments of aortic and peripheral vascular diseases.
Shanghai Micro Port Endovastec , a subsidiary of Micro Port®(00853.HK), was founded in Shanghai in 2012 and listed on the STAR Market (Stock code: 688016) of the Shanghai Stock Exchange on July 22, 2019.
Endovastec is committed to the R&D, manufacturing and sales of aortic and peripheral vascular interventional devices. It is one of the largest manufacturers of aortic products in China and has a rapidly growing market share globally. The Company has 13 NMPA registered products, 5 CE mark certificates and 6 entries in the NMPA Special Approval Procedure of Innovative Medical Devices. The company has more than 800 employees in China and worldwide.
More company and product information can be found at
Job Description:
Responsible for product design quality control including establishment, maintenance, optimization and effectiveness evaluation of product evaluation methods, design and change verification in product life cycle, product shelf-life verification, raw material quality evaluation, etc.;
Responsible for product quality control, including establishment of inspection points, formulation and implementation of quality control plans, as well as handling and resolution of quality abnormalities;
Responsible for product risk management and implementation of annual product risk management;
Responsible for audit of product quality related work completed by other people;
Perform other duties as assigned.
Job requirements:
Bachelor’s Degree in Engineering or Science is required
Mechanical Engineering, Materials Sciences, Polymer Science majors preferred
3-5 years of experience in medical device quality assurance preferred
Prior internal and external audit experience (FDA, EU Notified Bodies, ISO, etc.) preferred
Proficiency in Solid Works/CAD preferred
Mandarin speaking a plus
Perks:
We offer competitive pay, as well as excellent benefits options including medical, dental, & vision, and individual supplemental insurance options. Additionally, we offer a 401K plan with employer matching, paid holidays and a PTO policy.
About Micro Port®:
Micro Port® was founded in a very small office in Shanghai, China in 1998 when a group of dedicated individuals joined together by the common belief that advancements in medical technology could transform patients’ lives. Over the last two decades, Micro Port® has taken important steps towards fulfilling its mission of providing trustworthy and universal access to state-of-the-art solutions of prolonging and reshaping all lives.
Micro Port was listed on the main board of Hong Kong Stock Exchange in 2010. Currently we have 2 subsidiaries spun off and separately listed on the mainland Hong Kong Stock Exchange respectively.
To learn more, please visit our website:
Linked In page:
Micro Port and its subsidiaries are proud to provide equal-opportunity employment to all employees and applicants, without regard to race, creed, color, religion, national origin, citizenship, ancestry, age, veteran status, disability, pregnancy, marital status, genetic information, or any other categories protected by federal, state, or local law. As per company policy, official hiring will be pending the results of a background check and drug test.
Title: Senior Quality Assurance Engineer
Company: MicroPort Endovastec
Location: Irvine, California, USA
Category: Quality Assurance – QA/QC (Quality Engineering, QA Specialist / Manager), Engineering (Quality Engineering, Biomedical Engineer, QA Specialist / Manager)
