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Complaint Investigation Specialist II
- Posted 22 May 2023
- Salary US$60000 - US$85000 per annum
- LocationIrvine
- Job type Temporary
- DisciplineLife Sciences
- ReferenceBBBH148280_1684792863
- Contact NameMelody Lam
Job description
Complaint Investigation Specialist Job Responsibilities:
- Performs technical product investigations associated with complaints, collaborating with R&D Engineers, Manufacturing Engineers, Quality Engineers and Clinical, when necessary.
- Documents and codes device analysis and failure investigation root cause.
- Conducts device history record reviews, root cause analysis and database reviews for the Complaint Investigation Summary.
- Supports activities related to CAPA, NCMR, and related document control functions when required by complaint investigations.
- Assures documents are accurate, and verifiable against source materials to confirm compliance and traceability.
- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Builds productive internal/external working relationships.
- Normally receives little instruction on day-to-day work, general instructions on new assignments.
- Prepares returned complaint devices for investigation and trains staff on handling and cleaning products to control potential exposure to blood borne pathogens.
- Conducts risk assessments, device history record reviews, and database reviews for the Complaint Investigation Summary.
- Normally receives little instruction on day-to-day work, general instructions on new assignments.
- Responsible for compliance with quality system procedures and all regulatory requirements.
Background requirements:
- Bachelor's degree with 3+ years related hands-on experience
- Previous medical device complaint investigation experience required.
- Experience with Quality System requirements as it relates to CAPA, NCMR, audits and other relevant quality processes.
- Applied understanding of 21 CFR 820 and ISO 13485.
- Must be skilled at managing a significant workload and obtaining positive results, taking on additional responsibility and managing priorities as needed.
- Must be accurate, detailed, committed to high quality standards and pro-active in finding solutions to achieve successful outcomes.
- Master Control experience desired.
