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Careers at Hansen Medical

Sr. QA Specialist, Product Complaints

Summary:

Sustain product complaint activities for Hansen Medical. Ensure complaint handling tasks are completed as required by company policies and procedures as well as compliant with applicable industry regulations (e.g. FDA 21 CFR Part 820.198, ISO 13485:2003, etc.). Maintain overall effectiveness of complaint management program.

Responsibilities:

• Receive incoming reports on real and/or perceived issues and maintain tracking system
• Coordinate Complaint Assessment Team meetings when necessary
• Communicate assignments to Complaint Owners and follow-up routinely on investigation status
• Manage returned material (RMA) inventory
• Collaborate with technical and/or clinical groups to ensure thorough product analysis and documentation process
• Ensure records of complaint investigations are adequate, accurate and timely (within company target)
• Ensure effective CAPA is taken
• Attend departmental meetings to review status of open and/or overdue items
• Perform trend analysis and associated reports to alert management to any trends
• Manage both electronic and hard-copy product complaint files
• Identify and implement workflow improvements to increase the effectiveness, integrity and/or timely management of complaint files
• Assist with preliminary product failure analysis as assigned
• Assist Regulatory with MDR and/or Vigilence assessments and completion of reports as assigned
• Perform other relevant tasks as assigned

Requirements:

• B.S. in a technical discipline
• 2-3 years experience, with 1+ years direct complaint handling experience, in the Medical Device industry
• Experience with catheters and/or a capital equipment/software product is preferred
• Experience with 21CFR Part 820 (QSR), ISO 13485:2003, the EU Medical Device Directive (MDD) 93/42 EEC and 21CFR Part 11
• Quality-focused and self-directed, with excellent prioritization and verbal/written skills
• Solid computer skills with MS Office and enterprise databases
• Knowledge of MasterControl and QAD software a plus

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