CQR Engineer - Quality Product Complaints Specialist

Job description:

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).

Key responsibilities:

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

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

·       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.

·       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!

·       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.

·       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!

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

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

Required Skills:

·       We are looking bachelor’s degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.

·       We are looking 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 multi-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.

·       Outstanding analytical and problem-solving skills.

·       Always eager to learn and improve.

·       Strong interpersonal and writing skills.

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