Complaint & CAPA Analyst - Regulatory Quality

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

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.