Haemonetics Product Complaint Investigator II in Mexico
Title: Product Complaint Investigator II
Job Number: 161111748
Assist with the processing of Complaint Handling. Responsibilities include tracking, evaluation/investigation, probable/root cause determination and documenting of correction/corrective action assessment on customer complaints. Responsibilities also include involvement in any related NCMRs and the initiation of Impact Assessments and required escalations including support from leadership if required for related CAPAs.
• Accountable to provide input to the risk management process for updates to design documentation as result of determination of root cause as needed.
• Conducts higher level data analysis and utilizes reporting tools with ability to present data and results in a comprehensive, detailed, and organized fashion.
• Escalates complaints/product performance issues to Management as required.
• Generates daily, weekly, and monthly trending reports as required.
• Manages the complaint return investigation lab to ensure adequate stocking of materials and investigational equipment to aid the accurate investigation purposes.
• Participates and supports process, policy improvements, and guidance for enhancement projects such as Lean projects, supporting action items, and the revision of Standard Operating Procedures (SOP’s) and work instructions (WI).
• Participates in Key Customer Audits to ensure highest level of total customer satisfaction and may be required to travel to Key Customer facilities.
• Partners with cross functional teams as part of the investigation process to resolve customer issues and complaints.
• Performs detailed engineering, biochemical and design analysis including risk assessment and hazard documentation review, including full scope review of manufacturing, design process as required.
• Responsible for documenting the full investigation process to include return and evaluation of complaint samples and investigations, performing adequate root cause analysis, collaborating with functional experts as needed; conducting product inspection, tear-down, and testing, as required.
• Upon analysis determines, develops, and proposes appropriate corrective actions to address root cause and mitigate product failures.
Required Bachelor's Degree Science/Engineering discipline
Required 1 year Experience in a regulated industry
Preferred Other Experience in the medical device industry
Required Other Equivalent combination of education and experience
Preferred Other Prior project management experience
Licenses and Certifications:
Preferred Knowledge of Lean manufacturing, 6 Sigma principles, and Green Belt