CAPA & Complaint Specialist

Brief Description

The CAPA and Complaint Specialist supports the Quality & Regulatory department in receiving and processing complaints and corrective/preventive actions in the Quality Management System (QMS). It will include reviewing Device History Records, performing Risk Analysis, conducting and assisting with investigations, root cause analysis, and maintaining accurate records. The role will also be to collaborate with other departments while conducting the activities.

Essential Functions

• Provide corrective/preventive action and customer issue/complaint support for Class I and Class II medical devices in US and global markets for the family of AMHI companies.
• Customer Issues/Complaints
• Review customer issues/complaints
• Follow up with initial reporters for additional complaint information as required
• Ensure timely processing of complaints including medical device reporting decision trees and complaint investigations within required timeframes
• Collaborate with other departments, as applicable, during complaint investigations
• Communicate any adverse events/reportable incidents to the Regulatory Compliance Specialist and Director.
• Corrective and Preventive Actions
• Define the problem, contain the problem, identify the root cause, and determine the corrective action plan
• Liaise with other departments as applicable to the issues
• Perform activities within required timeframes
• Risk Management
• Consider the impact of issues/complaints and corrective/preventive actions on risk.
• Update risk files as needed.
• Collaborate with QMS Team members to identify improvement opportunities and develop solutions.
• Participate in internal and external audits or inspections on CAPA and Customer Issue/Complaint related matters.
• Participate in meetings providing data analysis on CAPA and Customer Issue/Complaint information.
• Other tasks and responsibilities as assigned. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
• Understands and adheres to Quality & Compliance policies and procedures.
• Follows safety procedures and maintains a clean and safe work environment.
  

Requirements

EDUCATION AND/OR EXPERIENCE

• High school diploma required.
• Minimum 2 years professional experience in quality management, or related industry experience such as research & development, operations, etc.
• Professional experience in a regulated industry with experience related to medical devices, FDA requirements and ISO 13485 and other quality standards would be beneficial.
• Ability to travel independently up to 15% (domestic – to MPI location in Kansas City).
• Ability to perform detailed tasks with accuracy.
• Excellent writing, verbal communication and listening skills with strong skills in MS Office applications.
• Familiarity with electronic quality management systems (such as Grand Avenue)
• Ability to manage multiple projects in parallel with shifting priorities.
• Critical and analytical thinking skills to enable asking follow-up questions and looking deeply into areas of concern to solve problems.
• Knowledge of Root Cause Analysis tools (training may be provided)
• Knowledge of Risk Analysis (training may be provided)
• Ability to work independently and productively with minimal direction and comfortable working without clear operating procedures in some situations.
• Exercise initiative by taking ownership of your decision-making skills and proactively get things done.
  
  

Physical Requirements & Work Environment

• Occasionally lift to 50 pounds.
  
  

Ability to sit and use computer most of the workday.

Summary

We offer a competitive hourly salary in the $28.84 to $33.65 range, based on experience and qualifications, along with annual bonus and profit-sharing opportunities tied to performance.

Beyond pay, our market-leading benefits are designed to support your wellbeing. These include medical, dental, vision, and life insurance, as well as short- and long-term disability coverage. We also provide a health savings account with company match, a retirement plan with employer contributions through Vanguard, and access to the Granite Assistance Fund for support when it’s needed most. We value time for rest and personal growth, offering generous paid time off, including volunteer time off and paid holidays.

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