Complaint Analyst

Integrated Resources Inc.; West Chester (Chester County); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading company in workforce solutions is seeking a Customer Quality Specialist to support Post Market Regulatory Affairs activities. This role involves handling complaints and MDR submissions while collaborating with internal teams and external partners. Applicants should have a Bachelor's Degree and relevant experience, demonstrating strong critical thinking, detail orientation, and communication skills.

Qualifications

• Bachelor’s Degree or equivalent experience required.
• 2-4 years related work experience preferred.
• RAC or ASQ certifications are a plus.

Responsibilities

• Interface with Hospitals, Surgeons, and Internal employees for complaint reporting.
• Expedite investigations by collaborating with business partners.
• Participate in CAPA activities and act as CAPA task owner.

Skills

Collaboration and teaming skills

Critical thinking skills

Detail orientation

Prioritization and multi-tasking skills

Strong verbal and written communication skills

Knowledge of basic medical terminology

Problem solving/Root cause analysis skills

Education

Bachelor’s Degree or equivalent experience

RAC or ASQ certifications

Tools

MS Office

Job description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

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
• 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
• 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
• Collaboration and teaming skills
• Critical thinking skills
• Detail orientation
• 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