Job Description

Title: Quality Engineer II

Location: Irvine CA 92614

Call Notes for Engineering - Engr II

• Looking for Quality Engineer II
• Quality Engineer will be working with R&D and Manufacturing team both for Non conformances
• Not specifically looking for Pilot manufacturing experience, any NPD manufacturing experience will work
• Not looking for equipment validation IQ/OQ/PQ
• No cap on number of years of experience as long as they are comfortable with job
• Onsite role

Must have:

• 1 year of Quality Engineering experiences needed
• Inspection experience needed
• Nonconformance experience needed
• CAPA experience needed
• Bachelor degree in Engineering needed (Mechanical, Biomedical, Chemical, Industrial)
• Strong problem solving experience
• Someone who has worked with Manufacturing to fine tune process
• Regulated Industry experience needed

Nice to Have:

• Medical device experience
• Test Method validation experience

JOB DESCRIPTION-

Job Description: Job Description Summary

This Pilot Operations Quality Engineer II role partners on the development of delivery systems for clinical manufacturing for the Transcatheter Heart Valve (THV) Business Unit.

Job Description

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of Client’ innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will enable you to optimize product development to impact patients around the world with pioneering technology.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Client’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Education and Experience:

• Prior experience in medical device manufacturing or operations preferred

• Experience with computerized Manufacturing Execution System (MES) preferred

• Bachelor's Degree in relative Engineering field plus minimum of two (2) years medical device industry experience required

• Master's Degree in relative Engineering field plus minimum of one (1) years medical device industry experience required

About Mindlance:

Founded in 1999 , Mindlance has been ranked as one of the fastest growing US Staffing firms by SIA for 9 consecutive years. We provide workforce solutions to Global 1000 companies in Technology, Engineering, Finance, Clinical Research, Scientific, Digital/Creative/Marketing space.

Mindful of the opportunity gap, we provide balanced solutions for both employers and job seekers—elevating the standards of recruitment practice to a whole new level. Our aim is to make a difference in the lives of job seekers by providing them with opportunities that broaden career horizons and expand skill sets. We take pride in being a strong driver of mindfulness and balance at workplace.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

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