Job Description
We are seeking a dedicated Complaint Handling Specialist who will be responsible for preparing, reviewing, and analyzing customer complaint data to determine MDR reportability. The ideal candidate will ensure timely and accurate reporting, coordinate complaint information across various regions, and continuously improve our tracking and control systems.
ResponsibilitiesPrepare, review, and analyze customer complaint data to determine MDR reportability, ensuring all complaints are reviewed within one day of receipt.Prepare monthly customer complaint data trending and analysis on various product lines, translating findings into actionable items and CAPAs for product improvement.Coordinate all complaint information within the US, EU, and ROW, ensuring all product-related complaints are logged and processed in the QT9 complaint handling system.Monitor and improve tracking/control systems for complaint handling and MDR reporting, maintaining continuous improvement.Ensure thorough and complete complaint investigations, closing complaints with no major audit findings.Communicate the results of complaint investigations to sales representatives within three days of completing the investigation.Essential SkillsAnalysisComplaint handlingDocumentationReportingCorrective Action and Preventive Actions (CAPAs)Good Manufacturing Practices (GMP)Experience with MinitabQuality Management System (QMS)Additional Skills & QualificationsBachelor's degree - preferred2-4+ years’ experience in complaint handlingFamiliarity with common measurement instrumentsExperience with the implementation of corrective action programsKnowledge of FDA (cGMP), ISO 13485:2016, and CMDCAS/MDSAPProficiency in ERP systems, Microsoft Access, and related applicationsCommitment to excellence, high standards, and acute attention to detailExcellent written and oral communication skillsAbility to build relationships across diverse workgroupsStrong organizational, problem-solving, and analytical skillsAbility to manage priorities and workflowDemonstrated ability to plan and organize projectsGood judgment with the ability to make timely and sound decisionsWork Environment
You will be working in a small to mid-sized medical device manufacturing environment.
Pay and Benefits
The pay range for this position is $28.00 - $35.00
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Elgin,IL.
Application Deadline
This position will be accepting applications until Dec 21, 2024.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.