Quality Engineer II, Product / Post Market Surveillance - Edwards Lifesciences
Irvine, CA
About the Job
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ 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.
This Quality Engineer will support, perform, and/or complete assigned complaint investigations that include (but are not limited to) product failure analysis and complaint documentation review (device history record, complaint history, products instructions, risk management, etc.), and prepare technical investigation reports.
How you will make an impact:
+ Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
+ Support external regulatory or competent authority requests with complaint risk and metric analysis as needed.
+ Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
+ Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determination by investigation.
+ Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.
+ Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).
What you'll need (Required Qualifications):
+ Bachelor's Degree in Engineering/Scientific field with 2 years of experience in Quality Engineering or Quality Assurance; OR Master’s degree in Engineering or Scientific field with either no experience (or internship experience).
+ Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
+ Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
What else we look for (Preferred Qualifications):
+ Experience with medical devices and working under a medical device regulated environment
+ Complaints investigation experience and/or hands-on experience with device investigations
+ Demonstrated experience with risk management/risk assessments
+ Working in lab environment and familiar with common measurement/test equipment (calipers, micrometers, pressure gages, leak testing, etc)
+ Experience with data analysis and able to generate metrics for trending and review
+ Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
+ Basic understanding of statistical techniques
+ Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
+ Ability to manage competing priorities in a fast-paced environment
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $83,000 to $117,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
This Quality Engineer will support, perform, and/or complete assigned complaint investigations that include (but are not limited to) product failure analysis and complaint documentation review (device history record, complaint history, products instructions, risk management, etc.), and prepare technical investigation reports.
How you will make an impact:
+ Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
+ Support external regulatory or competent authority requests with complaint risk and metric analysis as needed.
+ Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
+ Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determination by investigation.
+ Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.
+ Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).
What you'll need (Required Qualifications):
+ Bachelor's Degree in Engineering/Scientific field with 2 years of experience in Quality Engineering or Quality Assurance; OR Master’s degree in Engineering or Scientific field with either no experience (or internship experience).
+ Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
+ Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
What else we look for (Preferred Qualifications):
+ Experience with medical devices and working under a medical device regulated environment
+ Complaints investigation experience and/or hands-on experience with device investigations
+ Demonstrated experience with risk management/risk assessments
+ Working in lab environment and familiar with common measurement/test equipment (calipers, micrometers, pressure gages, leak testing, etc)
+ Experience with data analysis and able to generate metrics for trending and review
+ Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
+ Basic understanding of statistical techniques
+ Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
+ Ability to manage competing priorities in a fast-paced environment
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $83,000 to $117,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Source : Edwards Lifesciences
