Complaint Quality Engineer II PMS

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. Its 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 Product 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 youll need (Required Qualifications):
Bachelors Degree in Engineering/Scientific field with 2 years of experience in Quality Engineering or Quality Assurance; OR Masters degree in Engineering or Scientific field with either no experience (or internship experience).
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
Experience in medical device (cardiovascular endovascular or other critical care/surgical products) healthcare or a related environment.
Complaints investigation experience and/or hands-on experience with device investigations
Demonstrated experience with risk management/risk assessments
Experience working in lab environment and familiarity 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 interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Knowledge of and adherence to Quality systems
Must be able to work in a team environment
Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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 $87000 - $123000 (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.