Edwards Lifesciences
Complaint Quality Engineer II - PMS
USA - California – Irvine · Mid · Internship
Sponsorship not specified$87k-$123kDetected 1 day ago
Data AnalysisPatient CareMedical DevicesLeadershipCommunication
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odds of building a lasting career here
26Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
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About the role
- 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.
- It's our driving force to help patients live longer and healthier lives.
Responsibilities
- Support external regulatory or competent authority requests with complaint risk and metric analysis as needed.
- Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.
Requirements
- 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 with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
Nice to have
- 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
Compensation
- For California, the base pay range for this position is $87,000 - $123,000 (highly experienced).
Company info
- Join us and be part of our inspiring journey.
- 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.
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This listing is sourced directly from Edwards Lifesciences's careers page and normalized into a canonical job model.