Job Title: Complaints Technical Investigator
Location: Thousand Oaks, California (Hybrid)
Job Summary: We are seeking an experienced professional to drive investigations of complaints and failure analysis within a medical device environment. Our team is committed to continuous improvement and ensuring device reliability by identifying root causes and supporting product enhancements through structured analysis and reporting.
Responsibilities:
- Lead evaluation of returned products, inspect reserve samples, and review batch records and complaint trends.
- Provide actionable insights to engineering teams for product improvements based on investigative findings.
- Partner with device engineering to develop and implement structured failure analysis processes and tools across current and future device platforms.
- Perform root cause analysis of product complaints using techniques such as fishbone diagrams, “5 Whys”, FMEA, and utilize laboratory equipment for forensic evaluation.
Required:
- Bachelor’s degree in engineering, chemistry, physics, biology, or a related science (other backgrounds may be considered with robust laboratory experience).
- Minimum of 5 years’ experience in complaints handling or failure analysis investigation in a medical device environment, ideally involving Class II and Class III devices.
- Proficiency with ISO systems, risk management (including ISO 14971 and FMEA), and protocol/report writing.
- Strong technical writing and presentation skills, with proven experience in developing, executing, and validating test methods and leading continuous improvement activities.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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