Kelly Services Complaint Analyst in Irvine, California
Kelly Services has an opening for a Complaints Analyst in Irvine, CA . This contract assignment is budgeted through the end of the year and requires all work be done onsite. The Complaints Analyst will be responsible for maintaining the quality processes associated with regulatory reporting and its procedures and controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards. This individual will review reportable and potentially reportable complaints from incoming calls, faxes, and emails from all areas of the world; ensure adequate information is received to warrant timely reporting, investigation, and closure of reportable complaints, including sound regulatory reporting decisions/justifications for worldwide reporting; applies standard practices and procedures, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.
Essential Duties and Responsibilities:
Responsible for the complaints regulatory reporting process timely submissions, closure, health authority requests etc.
Responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.
Evaluates all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service and Technical Services.
Understands basic principles, theories, concepts and techniques related to customer complaints.
Escalate critical issues for proper disposition as necessary.
May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Work is expected to result in the development of new or improved techniques or procedures.
Ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies and other applicable standards as pertains to medical devices.
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Bachelor’s Degree or equivalent experience
2-4 years of related work experience required
RAC or ASQ certifications a plus
Experience w/managing customer complaints in a database of sorts is a must
Experience working for a medical device manufacturer a plus
MDR submission experience preferred
Knowledge of 21 CFR section 820 and ISO 13485 preferred
Ability to work in a cross-functional matrix environment
Critical thinking skills
Detail orientation, organization, prioritization and multi-tasking skills
Strong verbal and written communication skills; active listening/ phone skills
Knowledge of basic medical terminology
Proficiency in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint)
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 firstname.lastname@example.org.
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 relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a 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 kellyservices.com and connect
with 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 is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.