Complaint Quality Engineer II - PMS

Edwards Lifesciences • Irvine, CA

2d

About The Position

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.

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 Haves

• 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

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.
• 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).

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level