Analysis Skills, Biotech and Pharmaceutical, Computer Skills, Detail Oriented, Documentation, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), Identify Issues, Investigative Reports, Laboratory, Medical Equipment, Microsoft Excel, Microsoft Word, Organizational Skills, Procedure Development, Process Development, Product Support, Quality System Requirements (QSR), Radiography, Record Keeping, Standard Operating Procedures (SOP)
Location: Alameda, CA
Duration: 5 Months Contract
Shift: 1:35 PM 10:05 PM
Job Summary The Complaint Investigations Technician is responsible for supporting medical device complaint investigations by inspecting returned products, performing troubleshooting activities, documenting findings, and following FDA-regulated procedures. This role requires strong attention to detail, technical aptitude, and the ability to follow established processes and work instructions.
Key Responsibilities - Receive, unpack, and inspect returned customer products.
- Investigate product complaints using troubleshooting guides and established procedures.
- Perform product assessments and X-ray screening activities.
- Document investigation findings and complete reports accurately.
- Categorize and process complaint-related materials.
- Follow FDA regulations, SOPs, and quality system requirements.
- Support product handling activities involving sharps and medical devices.
- Maintain accurate records and investigation documentation.
Required Qualifications - High School Diploma or equivalent required.
- Strong computer skills, including Microsoft Excel and Word.
- Excellent attention to detail and organizational skills.
- Ability to follow detailed procedures and work instructions.
- Strong troubleshooting and analytical abilities.
- Ability to learn and retain technical information.
Preferred Qualifications - Engineering, Science, Laboratory, or Technical background.
- Complaint investigation experience.
- Medical device, pharmaceutical, or regulated industry experience.
- Internship or laboratory experience.
- Knowledge of SOPs, GMP, or FDA-regulated environments.