Complaints Quality Engineer II - PMS

Edwards Lifesciences • Irvine, CA

8d • $87,000 - $123,000

About The Position

The Complaints Quality Engineer II supports, performs, and completes assigned complaint investigations. Investigations may include product failure analysis and review of complaint documentation, such as device history records, complaint history, product instructions, and risk management information. The role prepares technical investigation reports and supports complaint quality and compliance activities for Edwards’ Transcatheter Heart Valve business unit.

The engineer investigates complex manufacturing product quality and compliance issues reported from the field, analyzes results, determines root or probable cause, and initiates and reviews reports. The role assesses reported events against established risk documentation, supports external regulatory or competent authority requests with complaint risk and metric analysis, and participates in escalation activities such as Product Risk Assessments and CAPAs or SCARs. The position also identifies complaint metrics by device category and collaborates with manufacturing engineering teams to resolve production- or device-related issues. Other incidental duties may include ad hoc complaint analysis or metric review.

Healthcare-interacting positions require COVID-19 vaccination, subject to a valid religious or medical exemption. The California base pay range is $87,000–$123,000, with pay dependent on qualifications, education, and prior experience.

Requirements

• Bachelor’s degree in an engineering or scientific field and 2 years of experience in Quality Engineering or Quality Assurance; or a master’s degree in an engineering or scientific field with no experience or internship experience.
• Experience with root cause analysis or investigations for complaints, nonconformance reports (NCRs), and/or CAPAs.
• Ability to follow company rules and requirements, including applicable pandemic protocols and Environmental Health & Safety rules, and take adequate measures to prevent injuries and protect the environment and prevent pollution within their span of influence or control.
• Ability to work in a team environment.

Nice To Haves

• Experience with medical devices and working in a regulated medical device environment.
• Experience in medical devices (including cardiovascular, endovascular, or other critical care or surgical products), healthcare, or a related environment.
• Complaints investigation experience and/or hands-on device investigation experience.
• Demonstrated experience with risk management or risk assessments.
• Laboratory experience and familiarity with common measurement and test equipment, such as calipers, micrometers, pressure gauges, and leak testing.
• Experience with data analysis and generating metrics for trending and review.
• Good documentation, communication, interpersonal, negotiating, and relationship management skills.
• Basic understanding of statistical techniques.
• Solid understanding and knowledge of engineering principles, theories, and concepts.
• 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.

Responsibilities

• Investigate complex manufacturing product quality and compliance issues reported from the field; analyze results, determine root or 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 risks, escalating to Quality Management and Product Safety as needed.
• Participate in escalation tasks and activities, including Product Risk Assessments (PRA) and corrective/preventive actions (CAPAs) or supplier corrective action requests (SCARs), as determined by the investigation.
• Identify and report key complaint metrics by device category and collaborate with applicable manufacturing engineering teams to resolve production- or device-related issues.
• Perform assigned complaint investigations, including product failure analysis and complaint documentation review, and prepare technical investigation reports.
• Assist with ad hoc complaint analysis or metric review as assigned by leadership.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of employees and their families

What This Job Offers

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