Quality Complaints Specialist

3 days ago


Hyderabad, India Tek Support Full time

Position Overview:

We are seeking an experienced Quality Complaints Specialist to manage and investigate customer complaints related to medical device products. This role involves ensuring all complaints are handled in compliance with regulatory requirements and company standards, while working closely with cross-functional teams to identify root causes and implement corrective actions. The ideal candidate will also provide insights for continuous improvement and ensure timely communication with regulatory bodies and customers.


Key Responsibilities:

  • Complaint Management: Oversee the intake, documentation, and processing of product complaints, ensuring they are logged and addressed in a timely manner.
  • Root Cause Investigations: Lead detailed investigations to identify the root cause of product complaints, collaborating with R&D, Manufacturing, Quality Assurance, and Regulatory Affairs teams.
  • Risk Assessment & Escalation: Evaluate complaints to determine risk and severity, escalating high-risk issues as needed to ensure swift resolution.
  • Documentation & Reporting: Maintain accurate and detailed records of all complaint investigations, ensuring compliance with regulatory standards and internal procedures.
  • Regulatory Compliance: Ensure compliant and timely reporting of adverse events to regulatory bodies, including CDSCO, US FDA, and EU MDR, in line with regulatory guidelines.
  • Trend Analysis: Analyze complaint data to identify trends and potential product quality issues, generating reports and presenting findings to leadership.
  • Continuous Improvement: Participate in initiatives aimed at improving the complaint handling process, providing valuable feedback to product design and manufacturing teams.
  • Customer Communication: Serve as a point of contact for customers regarding product complaints, providing timely updates and resolutions.


Required Qualifications:

  • Experience: 3-5 years of experience in a quality complaints role, ideally within the medical device industry.
  • Technical Skills:
  • Proficiency in complaint management systems and root cause analysis.
  • Strong knowledge of regulatory standards, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
  • Hands-on experience with Corrective and Preventive Action (CAPA) processes.
  • Analytical Skills: Ability to analyze data and identify trends to inform product improvement efforts.
  • Communication Skills: Strong verbal and written communication skills for interaction with customers, internal teams, and regulatory authorities.


Preferred Skills:

  • Experience working with regulatory bodies and knowledge of global medical device regulations.
  • Familiarity with complaint handling best practices and continuous improvement methodologies.



  • Hyderabad, Telangana, India Amgen Full time

    Join Amgen's Mission to Serve PatientsIf you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...


  • Hyderabad, India Tek Support Full time

    Position Overview :We are seeking an experiencedQuality Complaints Specialistto manage and investigate customer complaints related to medical device products. This role involves ensuring all complaints are handled in compliance with regulatory requirements and company standards, while working closely with cross-functional teams to identify root causes and...


  • Hyderabad, India Tek Support Full time

    Position Overview:We are seeking an experienced Quality Complaints Specialist to manage and investigate customer complaints related to medical device products. This role involves ensuring all complaints are handled in compliance with regulatory requirements and company standards, while working closely with cross-functional teams to identify root causes and...


  • hyderabad, India Tek Support Full time

    Position Overview : We are seeking an experienced Quality Complaints Specialist to manage and investigate customer complaints related to medical device products. This role involves ensuring all complaints are handled in compliance with regulatory requirements and company standards, while working closely with cross-functional teams to identify root causes...

  • Quality Specialist

    7 days ago


    hyderabad, India ADCI HYD 13 SEZ Full time

    About the team:The Last Mile Analytics & Quality Team aims to ease the delivery process by continuously improving the accuracy of data used for optimizing the last mile process. The team partners with product, engineering, data science and operations to identify gaps in the existing technology and implement sustainable and long-term solutions to minimize...

  • Quality Specialist

    3 months ago


    Hyderabad, India ADCI HYD 13 SEZ Full time

    About the team: The Last Mile Analytics & Quality Team aims to ease the delivery process by continuously improving the accuracy of data used for optimizing the last mile process. The team partners with product, engineering, data science and operations to identify gaps in the existing technology and implement sustainable and long-term solutions to minimize...


  • Hyderabad, India Arcolab Private Limited Full time

    Job Title : MICC (Medical Information Call Centre) SpecialistPrimary Responsibilities :• Handle inbound and outbound calls/emails for Adverse Events (AEs), Product Complaints (PCs) Medical Inquiries (MIS) and non-standard Inquires.• Handle spontaneous and solicited reports, including identification of Adverse Events, Product Complaints / Medical Device...


  • Hyderabad, India Quality Council Of India Full time

    Job Requirements Job Title: Customer Care Executive at QUALITY COUNCIL OF INDIA - BPO / Customer Care Role in Hyderabad, TelanganaCompany Name: QUALITY COUNCIL OF INDIALocation: Hyderabad, TelanganaSalary: ₹12,000 - ₹16,000 per monthQualification: 12th Standard / PUCJob Description:Handle incoming customer calls and emails in a professional and...


  • hyderabad, India Arcolab Private Limited Full time

    Job Title: MICC (Medical Information Call Centre) SpecialistPrimary Responsibilities:• Handle inbound and outbound calls/emails for Adverse Events (AEs), Product Complaints (PCs) Medical Inquiries (MIS) and non-standard Inquires.• Handle spontaneous and solicited reports, including identification of Adverse Events, Product Complaints / Medical Device...

  • Contract Specialist

    1 week ago


    Hyderabad, India Tekgence Inc Full time

    Job Title:-CONTRACT SPECIALISTExperience:-3 YearsLocation:-HyderabadJob Description:-A Contracts Specialist is a professional who drafts and reviews contractual agreements between companies and suppliers of products or services.Contracts Specialist responsibilities include:Negotiating contract agreements for products and servicesAssessing contractor...


  • Hyderabad, India Arcolab Private Limited Full time

    Job Title : MICC (Medical Information Call Centre) Specialist Primary Responsibilities : • Handle inbound and outbound calls/emails for Adverse Events (AEs), Product Complaints (PCs) Medical Inquiries (MIS) and non-standard Inquires. • Handle spontaneous and solicited reports, including identification of Adverse Events, Product Complaints / Medical...


  • Hyderabad, India Arcolab Private Limited Full time

    Job Title: MICC (Medical Information Call Centre) SpecialistPrimary Responsibilities:• Handle inbound and outbound calls/emails for Adverse Events (AEs), Product Complaints (PCs) Medical Inquiries (MIS) and non-standard Inquires.• Handle spontaneous and solicited reports, including identification of Adverse Events, Product Complaints / Medical Device...


  • Hyderabad, India Arcolab Private Limited Full time

    Job Title: MICC (Medical Information Call Centre) SpecialistPrimary Responsibilities:• Handle inbound and outbound calls/emails for Adverse Events (AEs), Product Complaints (PCs) Medical Inquiries (MIS) and non-standard Inquires.• Handle spontaneous and solicited reports, including identification of Adverse Events, Product Complaints / Medical Device...

  • Quality Specialist

    3 months ago


    hyderabad, India ADCI HYD 13 SEZ Full time

    The Last Mile Analytics & Quality Team in Hyderabad is looking for Transportation Quality Specialist who will act as first level support for driver and delivery related programs.Your solutions will impact our customers directly! This job requires you to constantly hit the ground running and your ability to learn quickly and work on disparate and overlapping...

  • Quality Specialist

    3 months ago


    Hyderabad, India ADCI HYD 13 SEZ Full time

    The Last Mile Analytics & Quality Team in Hyderabad is looking for Transportation Quality Specialist who will act as first level support for driver and delivery related programs. Your solutions will impact our customers directly! This job requires you to constantly hit the ground running and your ability to learn quickly and work on disparate and overlapping...

  • Quality Specialist

    7 days ago


    hyderabad, India ADCI HYD 13 SEZ Full time

    The Last Mile Analytics & Quality Team is looking for Language Specialists who will act as first level support for driver and delivery related programsYour solutions will impact our customers directly! This job requires you to constantly hit the ground running and your ability to learn quickly and work on disparate and overlapping tasks will define your...

  • Quality Specialist

    3 months ago


    Hyderabad, India ADCI HYD 13 SEZ Full time

    The Last Mile Analytics & Quality Team is looking for Language Specialists who will act as first level support for driver and delivery related programsYour solutions will impact our customers directly! This job requires you to constantly hit the ground running and your ability to learn quickly and work on disparate and overlapping tasks will define your...

  • Quality Lead

    4 weeks ago


    Hyderabad, India TechnipFMC Full time

    Quality Lead Location: Hyderabad, IN Employment type: Employee Place of work: Office Offshore/Onshore: Onshore TechnipFMC is committed to driving real change in the energy industry. Our ambition is to build a sustainable future through relentless innovation and global collaboration – and we want you to be part of it. You’ll be joining a culture that...

  • Contract Specialist

    1 week ago


    Hyderabad, India Tekgence Inc Full time

    Job Title:- CONTRACT SPECIALISTExperience:- 3 Years Location:- HyderabadJob Description:-A Contracts Specialist is a professional who drafts and reviews contractual agreements between companies and suppliers of products or services. Contracts Specialist responsibilities include:Negotiating contract agreements for products and servicesAssessing contractor...

  • Quality Manager

    1 week ago


    Hyderabad, India Scrabble Advisors Private Limited Full time

    1. To be the Company quality KPI owner, managing cost of quality activities, customer complaints and Field returns. Ensure timely and effective corrective and preventive actions taken to meet customer expectations.2. Maintain and improve Quality system, dealing with internal, support 3rd party and customer audit, to ensure the highest level of product...