Product Complaints Specialist

Overview

Senior role executing product complaint management, investigation and servicing requests for the Medline ANZ product complaint process, with support for coaching the complaint team and continuous improvement of complaint processes.

What you'll do

• Receive and review incoming product complaint submissions and verify 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 and apply established categorization and data entry requirements.
• Generate and issue complaint acknowledgement letters to customers and Account Managers within required timelines.
• Coordinate complaint workflow activities in accordance with approved procedures and establish and maintain follow-up schedules.
• Send routine follow-up communications to suppliers, manufacturers and internal stakeholders, 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.
• Route complaints to the appropriate ANZ Quality representative following initial review.
• Maintain investigation records and coordinate collection of investigation reports, supporting evidence, photographs, samples and supplier responses.
• Maintain complaint database integrity and prepare monthly complaint KPI reports and trend analyses.
• Monitor complaint metrics including volumes, aging, closure performance, product trends, supplier trends and recurring defects.
• Prepare dashboards, reports and summaries for review by ANZ Quality and provide supporting information for Management Review, Quality Review and Post-Market Surveillance activities.
• Ensure complaint records are maintained in accordance with applicable procedures and record retention requirements.
• Support audits and inspections through timely retrieval of complaint records and reports.

What you'll need

• Degree or higher in B. Tech (Biomedical), B.E. (Mech) or M. Pharm. (Quality Assurance).
• 5 to 7 years of work experience within the Medical Device industry, including experience in complaint handling, quality systems or post-market surveillance.
• Familiarity with 21 CFR Part 820 or ISO 13485 requirements.
• Excellent communication skills to convey clear, concise messages and instructions to internal and external stakeholders.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook), including creating and formatting professional documents, analyzing and organizing data, preparing presentations and managing communication and scheduling.
• Strong attention to detail and organizational skills, ensuring accuracy and compliance in data entry and documentation and managing multiple tasks efficiently.
• Strong focus on outcomes, setting clear goals, taking ownership and consistently delivering high-quality results aligned with business objectives.

Nice 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.

Details

• Location: Pune, India.
• Reports to the QRA Manager in India and the Quality Manager in the ANZ region.
• Working hours: 8:00 am to 5:00 pm.