Job description

This Senior Quality Engineer will conduct complaint investigations and risk assessments on reported device related complaints to determine root cause for appropriate action, escalation, and/or monitoring.

Key Responsibilities:
Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
Perform assessment for similar incident reportable complaints to identify rate and possible excursion from acceptable risks levels.
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.
Provide guidance and leadership as needed on key team projects/activities to help achieve team PMOs and THV Quality Objectives.
Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).

Required Qualifications:
Bachelor's Degree in Engineering/Scientific field with 4 years of experience in Quality Engineering or Quality Assurance; OR Master's Degree in Engineering/Scientific field with 3 years of experience in Quality Engineering or Quality Assurance
Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
Demonstrated experience with risk management/risk assessments

Preferred Qualifications:
Medical Device industry experience (will also consider pharma, biotech, or aerospace)
Experience with medical devices and working within a medical device regulated environment
Complaints investigation experience and/or hands-on experience with device investigations
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 $101,000 to $142,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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Disability accommodation for employment applicants
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Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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