Demo

Quality Complaints Specialist

capgemini
capgemini Salary
Richmond, VA Full Time
POSTED ON 2/4/2025
AVAILABLE BEFORE 4/4/2025

Responsible for managing and investigating product complaints to ensure that all complaints related to a company's products are properly handled, documented, and resolved in a timely manner.


This position is critical for maintaining product quality and customer satisfaction, as it focuses on analyzing complaints, identifying root causes, and implementing corrective and preventive actions (CAPA).

1.Manage incoming products complaints from customers, end users, or healthcare professionals. Ensure that complaints are properly documented in a complaint management system or database.

2.Evaluate and categorize complaints based on severity and impact. Ensure that serious or critical complaints (e.g., safety concerns, product defects) are escalated for immediate attention.

3.Ensure that all complaints are properly tracked, recorded, and investigated in accordance with internal policies, regulatory guidelines (e.g., FDA, ISO, GMP), and industry standards.

4.Collaborate with cross-functional teams (e.g., Quality Assurance, Manufacturing, R&D, Regulatory Affairs) to investigate the cause of the complaint. Conduct investigations to determine whether the complaint is related to product quality, packaging, labeling, or usage errors.

5.Use tools such as Fishbone diagrams, 5 Whys, or Failure Mode and Effects Analysis (FMEA) to conduct thorough root cause analysis to identify underlying issues causing the complaints.

6.Ensure that the company's quality management system (QMS) is updated with product complaint data and that all complaint-handling activities are in line with established procedures and policies.

7.Monitor and analyze complaint data to identify trends in product quality issues and provide regular reports to management on emerging trends, issues, or risks.

8.Prepare and deliver periodic reports on product complaints, including root causes, trends, corrective actions, and the effectiveness of CAPA

  • A bachelor?s degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
  • 3-7 years of Quality / relevant process experience in regulatory environment
  • Strong knowledge of complaint handling procedures, regulatory reporting requirements, and industry standards for quality management systems.
  • ?Proficiency with complaint management systems or databases and ability to manage large volumes of complaint data efficiently.
  • Strong communication skills to interact with cross-functional teams, senior management, and external auditors or regulators.
  • Excellent written and verbal communication skills for documenting complaints, preparing reports, and communicating effectively with customers and cross-functional teams.




The pay range that the employer in good faith reasonably expects to pay for this position is $25.43/hour - $39.73/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.


Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.

Salary : $25 - $40

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