CQR Technician - Quality Complaints Specialist

Job description:

Responsible for managing and investigating product complaints to ensure that all complaints related to a company's products are accurately 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 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 raised 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 multi-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 for a 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 multi-functional teams.

• Outstanding analytical and problem-solving skills.

• Always eager to learn and improve.

• Strong interpersonal and writing skills.

Life at Capgemini

Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:

• Flexible work
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

About Capgemini Engineering

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 360,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2023 global revenues of €22.5 billion.

Get the Future You Want | www.capgemini.com

Disclaimer

Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.

Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.