Product Complaints Specialist

Medline Industries; Pune District; In loco; INR 800.000 - 1.200.000; Tempo pieno

Descrizione del lavoro

Medline India is seeking a Product Complaints Specialist to manage the product complaint lifecycle, from intake through investigation and closure, ensuring compliance with quality standards.

The role requires a B.Tech/BE in Biomedical/Mech or M.Pharm QA with 5–7 years in the medical device sector. Experience with 21 CFR Part 820 or ISO 13485 is preferred. Strong communication and MS Office skills are essential.

Competenze

• Degree in B.Tech/BE Biomedical/Mech or M.Pharm QA.
• 5–7 years in medical device complaint handling or post-market surveillance.
• Familiarity with 21 CFR Part 820 or ISO 13485.
• Strong communication and MS Office skills.

Mansioni

• Handle intake and administration of product complaints.
• Coordinate workflow and follow-up with stakeholders.
• Support investigations with documentation and evidence.
• Prepare KPI reports and assist with post-market surveillance.
• Ensure compliance with quality systems and record retention.

Conoscenze

Complaint handling

Quality systems

Post-market surveillance

MS Office

Formazione

B.Tech/BE Biomedical/Mech or M.Pharm QA

Strumenti

Power BI

Power Apps

ERP

Descrizione del lavoro

Job SummaryTheProduct Complaints Specialist role is responsible for executing all aspects ofproduct complaint management, investigation, and servicing requests. Thissenior role also assists with coaching and mentoring the complaint team, performingadditional quality activities as needed for the division, and working oncontinuous improvement initiatives related to complaint processes.Job DescriptionProduct Complaints SpecialistAbout Medline: About Medline India:Medline India was setup in 2010 in Pune, primarily as an offshore Development centre and to augment resources for Medline Industries LP headquartered in Chicago, USA. We are a 1500+ strong and growing team of technology, finance & and business support professionals who support our businesses worldwide towards a mission to make healthcare run better. We are proud to be certified as a ‘Great Place to Work’ by the Great Place to Work Institute (India) for the duration May 2023 – May 2024.We are an organization with a conducive work environment, ample opportunities to learn, contribute and grow with a highly empowered & engaged team. We encourage our people to share their best ideas and create new opportunities for our customers and ourselves to work together to solve today’s toughest healthcare challenges.About Medline Industries, LP:Established in 1966, Medline Industries LP is a renowned global healthcare organization boasting 56 years of consecutive sales growth, exceeding $21 billion in annual sales. With a workforce of over 36,000 professionals spread across the globe, we operate in more than 125 countries and territories. As the largest privately held manufacturer and distributor of medical supplies in the United States, Medline is uniquely positioned to offer comprehensive products, education, and support across the continuum of care.At present, Medline Industries, LP holds the esteemed position as the #1 market leader, delivering an extensive portfolio of over 550,000 medical products and clinical solutions. Our clientele includes hospitals, extended care facilities, surgery centres, physician offices, home care agencies, providers, and retailers.We're proud to be recognized by Forbes as one of America’s Best Large Employers and Best Employers for Women. Additionally, the Chicago Tribune has consistently named us a Top Workplace for the past 12 years.Job DescriptionThe Complaints & Post-Market Surveillance (PMS) role is responsible for the efficient administration and coordination of the Medline ANZ product complaint process. The role ensures complaints are accurately received, documented, tracked, and reported in accordance with established procedures and regulatory requirements.The role provides operational support through complaint intake, workflow management, data integrity, trending, and reporting activities.We are looking for someone who thrives in a team environment, demonstrates a strong sense of urgency, and can build and maintain effective working relationships with peers, customers, and suppliers.The role reports to the QRA Manager in India and the Quality Manager in the ANZ region.Key ResponsibilitiesComplaint Intake and Case AdministrationReceive and review incoming product complaint submissions.Verify complaint information for completeness, accuracy, and documentation requirements.Contact Account Managers, or internal stakeholders to obtain missing information where required.Create and maintain complaint records within designated systems.Apply established categorization, and data entry requirements.Generate and issue complaint acknowledgement letters to customers / Account Managers within required timelines.Ensure complaint records are maintained accurately and completely throughout the complaint lifecycle.Workflow Coordination and Follow-UpCoordinate complaint workflow activities in accordance with approved procedures.Establish and maintain complaint follow-up schedules.Send routine follow-up communications to suppliers, manufacturers, and internal stakeholders as required.Monitor outstanding actions and responses and escalate overdue items to ANZ Quality for review.Track complaint milestones and support achievement of complaint processing KPIs.Support the transition to automated workflow management tools such as Power Apps where applicable.Investigation SupportRoute complaints to the appropriate ANZ Quality representative following initial review.Maintain investigation records and supporting documentation.Coordinate collection of investigation reports, supporting evidence, photographs, samples, and supplier responses.Monitor completion of investigation activities and maintain visibility of outstanding actions.Support ANZ Quality by ensuring all required documentation is available for review and closure decisions.Data Analysis, Trending and ReportingMaintain complaint database integrity and ensure accurate complaint information.Prepare monthly complaint KPI reports and trend analyses.Monitor complaint metrics, including complaint volumes, aging, closure performance, product trends, supplier trends, and recurring defects.Identify emerging patterns and potential signals through structured analysis.Prepare dashboards, reports, and summaries for review by ANZ Quality.Provide supporting information for Management Review, Quality Review, and Post-Market Surveillance activities.Compliance and DocumentationEnsure complaint records are maintained in accordance with applicable procedures and record retention requirements.Maintain complaint correspondence, acknowledgement letters, investigation documentation, and supporting records.Support audits and inspections through timely retrieval of complaint records and reports.Follow established quality system procedures and complaint handling requirements.Must HaveDegree or higher in B. Tech (Biomedical)/ B.E. (Mech)/ M. Pharm. (Quality Assurance).5-to-7-years work experience within the Medical Device industry experience in complaint handling, quality systems, or post-market surveillance.Familiarity with 21 CFR Part 820 or ISO 13485 requirements.Demonstrates excellent communication skills to convey clear, concise messages and instructions to internal and external stakeholders, ensuring alignment and understanding.Proficiency in MS Office (Word, Excel, PowerPoint, Outlook): Able to create and format professional documents, analyze and organize data, prepare clear presentations, and manage communication and scheduling effectively.Strong attention to detail and organizational skills: Ensures accuracy and compliance in data entry and documentation, maintains structured records, and manages multiple tasks efficiently.Demonstrates a strong focus on outcomes by setting clear goals, taking ownership, and consistently delivering high-quality results that align with business objectives.Good to HaveExperience with ERP, Power BI, Power Apps, or quality management systems.Experience producing KPI dashboards and trend reports.Working exposure in the ANZ regional regulatory environment.Exposure to global quality systems and multi-country document management.Ability to work independently and in a global team environment.Familiarity with CAPA management, Change management, and other quality activities.Working Hours:8:00 am to 5:00 pmAbout Medline India:Medline India was setup in 2010 in Pune, primarily as an offshore Development centre and to augment resources for Medline Industries LP headquartered in Chicago, USA. We are a 1500+ strong and growing team of technology, finance & and business support professionals who support our businesses worldwide towards a mission to make healthcare run better. We are proud to be certified as a ‘Great Place to Work’ by the Great Place to Work Institute (India) for the duration May 2023 – May 2024.We are an organization with a conducive work environment, ample opportunities to learn, contribute and grow with a highly empowered & engaged team. We encourage our people to share their best ideas and create new opportunities for our customers and ourselves to work together to solve today’s toughest healthcare challenges.About Medline Industries, LP:Established in 1966, Medline Industries LP is a renowned global healthcare organization boasting 56 years of consecutive sales growth, exceeding $21 billion in annual sales. With a workforce of over 36,000 professionals spread across the globe, we operate in more than 125 countries and territories. As the largest privately held manufacturer and distributor of medical supplies in the United States, Medline is uniquely positioned to offer comprehensive products, education, and support across the continuum of care.At present, Medline Industries, LP holds the esteemed position as the #1 market leader, delivering an extensive portfolio of over 550,000 medical products and clinical solutions. Our clientele includes hospitals, extended care facilities, surgery centres, physician offices, home care agencies, providers, and retailers. We are proud to be recognized by Forbes as one of America’s Best Large Employers and Best Employers for Women. Additionally, the Chicago Tribune has consistently named us a Top Workplace for the past 12 years.