Complaint Analyst II

Pioneer Data; West Chester (Chester County); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading healthcare technology firm in Chester County is seeking a Customer Quality Specialist responsible for supporting Post Market Regulatory Affairs. This role includes handling complaint investigations, documentation, and regulatory reporting. The ideal candidate will have a Bachelor’s degree or equivalent, strong communication and problem-solving skills, and proficiency in MS Office. They will work closely with various teams to ensure compliance and facilitate effective complaint management.

Qualifications

• Ability to work in a cross-functional matrix environment.
• Experience collaborating with different teams.
• Proficiency in basic medical terminology is needed.

Responsibilities

• Interface directly with Hospitals, Surgeons, and Internal employees.
• Conduct investigations on complaints and adverse events.
• Report and document complaints timely and accurately.
• Participate in CAPA activities and be an active task owner.

Skills

Collaboration and teaming skills

Critical thinking skills

Prioritization and multi-tasking skills

Strong verbal and written communication skills

Knowledge of basic medical terminology

Proficiency in MS Office

Continuous learner

Accountability for own work

Problem solving/Root cause analysis skills

Education

Bachelor’s Degree or equivalent experience

2-4 years of related work experience

RAC or ASQ certifications

Tools

MS Office (Word, Excel, Outlook, PowerPoint, Sharepoint)

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
• Reportability assessments
• Conduct follow-ups with complainant, reporters
• Checking your own work
• 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

PROFESSIONAL EXPERIENCE REQUIREMENTS

Ability to work in a cross‑functional matrix environment

• Collaboration and teaming skills
• Critical thinking 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
• Accountability for own work
• Problem solving/Root cause analysis skills

EDUCATIONAL REQUIREMENT

• Bachelor’s Degree or equivalent experience
• Generally requires 2-4 years of related work experience
• RAC or ASQ certifications a plus

Additional Information

All your information will be kept confidential according to EEO guidelines.