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Complaint Resolution Expert
2 weeks ago
A rapidly growing and innovative medical device technology company in south Orange County is seeking a Complaint Resolution Expert on a long-term contract basis with potential for full-time transition. The key responsibilities include leading investigation activities for reported complaints, collaborating with engineers and subject matter experts to ensure thorough documentation and effective feedback into design development and risk management processes.
Key Responsibilities:- Acknowledge and document incoming complaints accurately and promptly.
- Perform device analysis according to established procedures and work instructions.
- Conduct follow-up communications with customers and relevant personnel to gather additional information.
- Analyze and review available data to determine the root cause(s) of alleged product deficiencies.
- Compose detailed reports describing results from investigation activities.
- Complete investigations and close complaints in a timely and accurate manner.
- Provide training on best practices for complaint handling processes.
- Identify patterns in complaints and propose corrective/preventive actions as required.
- Bachelor's Degree in a scientific or technical field with at least two years of experience in a related field (highly preferred).
- Completion of required training per the training plan for this position, maintained in the document control system.
- ASQ certification recommended but not required.
- Ability to read, analyze, and interpret complaints and adverse events with understanding of basic medical terminology.
- Knowledge of quality system requirements in various markets including the US, EU, UK, Mexico, Canada, Australia, Brazil, Japan, South Korea, and other regions.
- Curious mindset with strong sense of integrity, accountability, and commitment to exceptional service.
- Excellent writing and computer skills.
- Independence in completing work assignments with minimal supervision/guidance.