QA Complaint Intake Specialist

R&D Partners; San Diego (CA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Online timecard approval

Job summary

R&D Partners is seeking a QA Complaint Intake Specialist in San Diego, CA. The role involves receiving and assessing complaint information from various channels, documenting events in the eQMS, and coordinating follow-up with internal and external stakeholders. Candidates should have 1-3 years of relevant experience, a BS/BA degree in a related field, and strong organizational and communication skills. A comprehensive benefits package including medical insurance and a 401k plan is offered.

Qualifications

• 1-3 years of relevant experience in Quality Assurance or regulated industries.
• Basic understanding of medical device and quality system requirements.
• Experience with complaint handling systems preferred.

Responsibilities

• Receive complaint information from various sources.
• Review and document complaint information accurately.
• Perform initial complaint triage activities.
• Coordinate follow-up activities with stakeholders.

Skills

Attention to detail

Organizational skills

Communication skills

Ability to manage multiple records

Education

BS/BA degree in a scientific, technical, healthcare, or quality-related discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

eQMS systems

Job description

R&D Partners is seeking to hire a QA Complaint Intake Specialist in San Diego, CA.

Your main responsibilities as a QA Complaint Intake Specialist:

• Receive complaint information from approved intake sources including Customer Support, field personnel, sales representatives, Medical Affairs, email communications, phone calls, and other authorized channels.
• Review incoming complaint information and supporting documentation to assess reported events, identify potential complaint criteria, and initiate required follow-up activities.
• Accurately document complaint information within the complaint handling module/eQMS.
• Perform initial complaint triage activities to assess completeness of available information, identify missing or unclear details, and determine the need for additional follow-up or escalation.
• Coordinate and document follow-up activities with internal and external stakeholders to obtain missing, incomplete, or clarifying information necessary for complaint assessment and investigation.

What we are looking for in a QA Complaint Intake Specialist:

• Minimum 1-3 years of relevant experience in Quality Assurance, medical device/pharmaceutical documentation, customer support, or another regulated industry preferred.
• Medical device or pharmaceutical experience is preferred.
• BS/BA degree in a scientific, technical, healthcare, or quality-related discipline is desirable; equivalent experience may be considered.
• Experience with eQMS, complaint handling systems, or regulated documentation is preferred.
• The individual should have a basic understanding of medical device and quality system requirements; strong organizational skills; strong attention to detail; ability to accurately review and document information; ability to determine the number of complaint events from emails and supporting communications; ability to identify missing or unclear information; ability to coordinate timely follow-up; good written, verbal, and interpersonal communication skills; ability to work professorially with cross-functionally teams, Complainant, Customer Support, Field Sales, Medical Affairs, QA, Operations, and Complaint Investigators; ability to manage multiple complaint records within required timelines; and working knowledge of Microsoft Word, Excel, Outlook, and eQMS systems.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance - PPO, HMO &
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Online timecard approval

R&D Partners is an equal-opportunity employer.