Complaints Quality Engineer II - PMS

Edwards Lifesciences • Irvine, CA

6d

About The Position

The Complaints Quality Engineer II supports, performs, and completes complaint investigations, including product failure analysis, review of complaint documentation such as device history records, complaint history, product instructions, and risk management materials, and preparation of technical investigation reports. The role investigates complex manufacturing product quality and compliance issues reported from the field and supports regulatory or competent authority requests with complaint risk and metrics analysis as needed.

The engineer assesses reported events against established risk documentation, escalates issues to Quality Management and Product Safety when needed, and participates in product risk assessments and corrective and preventive actions, including CAPAs and SCARs. The position also identifies and reports complaint metrics by device category and collaborates with manufacturing engineering teams to resolve production- or device-related issues. Other incidental duties, including ad hoc complaint analysis or metric review, may be assigned by leadership.

Requirements

• Bachelor's degree in an engineering or scientific field and 2 years of experience in Quality Engineering or Quality Assurance; alternatively, 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.
• Good documentation, communication, and interpersonal relationship skills, including negotiating and relationship management skills.
• 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.
• Ability to work in a team environment.
• Adherence to company rules and requirements, including applicable pandemic protocols and Environmental Health & Safety rules.

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 experience with device investigations.
• 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 ability to generate metrics for trending and review.
• Basic understanding of statistical techniques.
• Solid understanding and knowledge of engineering principles, theories, and concepts.

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 (PRAs) and corrective/preventive actions (CAPAs and 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.
• Perform other incidental duties assigned by leadership, which may include ad hoc complaint analysis or metric review.
• Adhere to company rules and requirements, including Environmental Health & Safety rules, and take adequate control measures to prevent injuries and pollution and protect the environment within their span of influence or control.

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