Complaint Analyst III

Integrated Resources Inc.; Irvine (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company is seeking a Complaints Coding Specialist to manage and analyze customer complaints in the medical device sector. This role involves evaluating complaints from a technical perspective, ensuring regulatory compliance, and producing reports. Candidates should have a Bachelor's degree in a relevant field with extensive experience in an FDA regulated industry and demonstrate advanced critical thinking and multitasking abilities.

Qualifications

• 4-6 years related experience in medical device or FDA regulated industry.
• Strong written and verbal communication skills.
• Ability to understand complex procedures.

Responsibilities

• Review and analyze customer complaints for proper coding.
• Develop dashboards and reports to ensure timely complaint processing.
• Investigate complaint trends and document findings.

Skills

Engineering fundamentals

Critical thinking

Multitasking

Communication

Attention to detail

Education

Bachelor’s Degree in Science, Engineering, Nursing, Biology, Chemistry or related field

Tools

Siebel Complaint Management System

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

Duties:

• The Complaints Coding Specialist will review and analyze assigned to him/her customer complaints; and proper investigate the complaint and contact the customer if necessary.
• This individual will evaluate all information from a clinical and technical perspective to ensure appropriate Subject codes, Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
• The Complaints Coding Specialist will ensure proper documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.
• The Complaints Coding Specialist will develop, establish, prepare and distribute dashboards and reports to assure complaints are processed and coded in a timely manner.
• This individual will develop a thorough understanding of the complaint database.
• Additionally, The Complaints Coding Specialist will develop, prepare, and analyze reports for coded complaints on a weekly and monthly basis, as required.
• The Complaints Coding Specialist will escalate critical issues for proper disposition as necessary.
• Authors Clear, Technical, and Accurate Reports Describing Complaints and Investigations for Compliance Files
• Reviews Incoming Complaints and Completes Good-Faith Effort to Collect Additional Information as Required
• Independently Completes Medium Complexity Complaint Investigations within Required Timelines (e.g. "Out of the Box" Failure Investigations) Initiates Company Issue Escalation Process as Required
• Investigates and Documents Complaint Trend Analyses
• Coordinates Initiation of Company CAPA Process as Required
• Makes Significant Contributions to Improvement Initiatives
• Contributes to Document Change Orders
• Maintains Compliance to Applicable Foreign and Domestic Regulations Governing the Management and
• Processing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy Laws
• Performs other duties assigned as needed

Qualifications

Required Minimum Education:

• Bachelor’s Degree or Equivalent - A degree in Science, Engineering, Nursing, Biology, Chemistry or related technical field
• 4-6 years related experience years related experience
• Experience in medical device or other FDA regulated industry.

Required Skills:

• Must possess the basic understanding of engineering fundamentals.
• Advanced critical thinking and investigation skills are required.
• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Candidate must be able to effectively prioritize and manage multiple activities and responsibilities.
• Ability to understand and follow complex written procedures is required.
• Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
• Ability to function in a team environment and deliver on team objectives is required. Ability to influence and drive change is preferred. Prefer project management and/or process mapping experience.
• Communication Skills: Strong written and verbal communication skills are required. Must be highly proficient in reading, writing, and speaking the English language.
• Technical writing is a routine part of this position. Strong attention to detail is required.

Required Computer Skills:

• Familiarity with computers and Windows-based PC applications.
• Ability to learn and manipulate complex computer system applications is required.
• Prefer experience with Siebel Complaint Management System.

Additional Information

Thanks!! With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x219

Inc. 5000 – 2007-2015 (9 Years in a row)