Product Complaints Specialist

Medline Industries India Pvt. Ltd.; Pune District; Sur place; INR 700 000 - 1 100 000; Plein temps

Résumé du poste

Medline Industries India Pvt. Ltd. seeks a Product Complaints Specialist to manage all aspects of product complaints, investigations, and servicing requests.

This senior role includes coaching the complaints team and driving continuous improvement in complaint processes. The role reports to the QRA Manager in India and collaborates with the ANZ Quality team. Must have 5–7 years in medical devices complaint handling, with strong data analysis and MS Office skills, and knowledge of ISO 13485/21

Qualifications

• Degree or higher in B. Tech (Biomedical) / B.E. (Mech) / M. Pharm (Quality Assurance).
• 5–7 years work experience in Medical Device industry with complaint handling, quality systems, or post-market surveillance.
• Familiarity with 21 CFR Part 820 or ISO 13485 requirements.
• Excellent communication to convey clear messages to stakeholders.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) for documents, data and scheduling.
• Attention to detail and strong organizational skills for data entry and documentation.

Responsabilités

• Handle complaint intake and case administration.
• Coordinate complaint workflow and follow-up with stakeholders.
• Support investigation records and collection of reports and evidence.
• Analyze data to identify trends, prepare KPI reports and dashboards.
• Ensure compliance with procedures and record retention requirements.

Connaissances

Quality Assurance

Communication

MS Office

Data Analysis

Formation

B.Tech/BE in Biomedical/Mechanical

M.Pharm (Quality Assurance)

Outils

Power BI

Power Apps

ERP

Description du poste

Job Summary

The Product Complaints Specialist role is responsible for executing all aspects of product complaint management, investigation, and servicing requests. This senior role also assists with coaching and mentoring the complaint team, performing additional quality activities as needed for the division, and working on continuous improvement initiatives related to complaint processes.

Job Description

Product Complaints Specialist About 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 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.

The 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 Responsibilities

• Complaint Intake and Case Administration
  • Receive 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-Up
  • Coordinate 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 elevate 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 Support Route complaints to the appropriate ANZ Quality representative following initial review.
  • Route 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 Reporting
  • Maintain 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 Documentation
  • Ensure 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 Have

• Degree 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 Have

• Experience 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

Working Hours: 8:00 am to 5:00 pm

About Medline India

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 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. Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you. Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.