Complaints Quality Engineer II - PMS

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences Gruppe in Irvine, CA seeks a Quality Engineer to support, perform, and complete complaint investigations, including root cause analysis and documentation review (device history record, complaint history, risk management, etc.).

You will investigate complex manufacturing quality issues, support CAPAs/SCARs, and contribute to risk assessments and metric reporting, working with cross-functional teams.

Qualifications

• Bachelor's degree in Engineering or Scientific field required; 2+ years in Quality Engineering or related role.
• Experience with root cause analysis or investigations for Complaints, NCRs, and CAPAs preferred.
• Experience in medical devices regulatory environment and risk management is desirable.
• Strong documentation, communication, and data analysis skills.

Responsibilities

• Investigate complex manufacturing quality and compliance issues reported from the field.
• Analyze results to determine root/probable cause and initiate/review reports.
• Support regulatory or competent authority requests with risk assessment and metrics as needed.
• Participate in risk assessments (PRA) and CAPAs, SCARs per investigation outcomes.
• Identify and report key complaint metrics and collaborate with manufacturing teams to resolve issues.

Skills

Root cause analysis

Data analysis

Risk assessments

Quality systems

Investigation experience

Education

Bachelor's degree in Engineering or Scientific field

Master’s degree in Engineering or Scientific field

Tools

Calipers

Micrometers

Pressure gauges

Leak testing equipment

Job description

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 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 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 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/controlAligning 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 $87,000 - $123,000 (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.Every employee is essential to Edwards’ success, and we’re ready to help you advance along your career path!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 or have a valid religious or medical exemption from being vaccinated.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.