Job Title: Complaints Technical Investigator
Location: Thousand Oaks, California (Hybrid)
Job Summary: We are seeking a skilled professional to join our team and support continuous improvement efforts for clinical and commercial drug delivery devices. Our team is dedicated to optimizing patient experience and ensuring reliable supply by driving robust technical investigations and adopting best practices for complaint trending and analysis.
Responsibilities:
- Conduct forensic evaluations of returned units, review batch records, and analyze complaint trends to determine root causes of design or usability issues.
- Partner with device engineering teams to develop and validate structured failure analysis processes and tools for current and future platforms.
- Lead root cause analysis activities using tools such as fishbone diagrams, “5 Whys”, FMEAs, Fault Tree Analysis, and facilitate the development of design solutions to minimize complaints.
- Generate comprehensive reports in accordance with established procedures, assist in laboratory equipment setup, train personnel, and develop or validate test methods and SOPs.
Required:
- Bachelor’s degree in engineering, chemistry, physics, biology, or related science field—or equivalent robust laboratory experience.
- Minimum 2 years’ experience for candidates with a bachelor’s degree, 6 years for associate degree holders, or 8 years with high school diploma/GED, ideally 5+ years’ hands-on complaints or failure analysis work within medical devices Class II or III.
- Demonstrated proficiency in protocol and report writing, risk analysis processes (such as ISO), and executing process and test development.
- Background in medical device, biotech, or biopharma industries; strong technical writing, interpersonal, and presentation skills.
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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