Complaint Analyst

Job Description

Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts.

DUTIES:

• Directly interface with Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events.

• Interact positively with customers, patients, internal/external business partners and colleagues

• Adhere and comply to work instructions, standard operating procedures, and regulations

• Expedite investigations by collaborating with internal/external business partners

• Achieve productivity targets

• Fully training within three months of hire

• Achieve accuracy targets for complaint documentations

• Participate in projects and events

• Complaint determination

• Report ability assessments

• Conduct follow-ups with complainant, reporters

• Checking your own work

• Updating SharePoint

• Tracking complaints in the process for closure

• Participate in CAPA activities and act as CAPA task owner as required

• Updating and revising work instructions

• Prepare responses to customers

• All other duties as assigned

Qualifications

EDUCATIONAL REQUIREMENTS:

• Bachelor’s Degree or equivalent experience/Masters with Reg affairs.

• Generally requires 2-4 years of related work experience

• RAC or ASQ certifications a plus

REQUIREMENTS:

• Ability to work in a cross-functional matrix environment

• Active listening/ phone skills

• Collaboration and teaming skills

• Critical thinking skills

• Detail orientation

• Organization skills

• Prioritization and multi-tasking skills

• Strong verbal and written communication skills

• Knowledge of basic medical terminology

• Proficiency in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint)

• Continuous learner

• Global mindset

• Accountability for own work

• Problem solving/Root cause analysis skills

Additional Information

Kind Regards,

Sasha Sharma

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - 732-662-7964