Complaint Investigation Specialist II

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.