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Complaints Coding Specialist

Kelly Services

Irvine, CA
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Complaints Coding Specialist

Jobid US33MXGR_BH1411328

Location: Irvine, CA, 92604, USA

Description Kelly Services has an opening for a Complaints Coding Specialist in Irvine, CA. This is a contract assignment currently budgeted through the end of August. The Complaints Coding Specialist will review and analyze customer complaints, properly 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.

Job duties include:

• Ensure proper documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.

• Develop, establish, prepare and distribute dashboards and reports to assure complaints are processed and coded in a timely manner.

• Develop a thorough understanding of the complaint database.

• Develop, prepare, and analyze reports for coded complaints on a weekly and monthly basis, as required.

• 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

Requirements & Qualifications

• Bachelor’s Degree or Equivalent - A degree in Science, Engineering, Nursing, Biology, Chemistry or related technical field

• 2-4 years related experience

• Experience in medical device or other FDA regulated industry.

• 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.

• 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

• Ability to type at least 50 words per minute (WPM)

• Experience with Microsoft Word and internet browsers (e.g. Internet Explorer)

• Experience with Siebel Complaint Management System is desired but not required

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

Perks of being a Kelly employee:

• Weekly electronic pay

• Access to more than 3,000 online training courses though Kelly Learning center

• Group rate insurance options available immediate upon hire*

• Service bonus plan and holiday pay*

• Online application system

• Never an applicant fee

*perks to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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