Title: Senior Quality Associate- Complaints
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 June 2025 – June 2026. 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 centers, 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 Description:
The Senior Quality Associate- Complaints is responsible for overseeing product complaint investigations to ensure compliance with internal procedures and regulatory requirements in compliance with 21 CFR 803/820, EU MDR 2017/745 and ISO 13485. This role involves receiving and documenting complaints, coordinating device returns, performing root cause analysis, supporting CAPA investigations, and maintaining audit-ready documentation while collaborating with cross-functional teams to resolve issues, supporting regulatory and post-market activities, and driving continuous improvement across the organisation. This role will report to the QRA Manager in India and the Senior Quality Manager in Europe.
Key Responsibilities:
- Manage end-to-end complaint handling by receiving and documenting complaints, coordinating device returns, evaluating returned products, performing initial risk assessments, and ensuring accurate categorisation in compliance with reporting standards.
- Perform root cause investigations for complaints using structured methodologies, validate outcomes, and ensure timely review and closure of complaints while maintaining clear, compliant, audit-ready documentation.
- Coordinate with cross-functional teams, including Quality Engineering, R&D, Design, Regulatory, Manufacturing, Marketing, Sales, and Operations, to analyse failures and drive resolutions.
- Collaborate with suppliers to manage and resolve complaint investigations by reviewing investigation reports and verifying the implementation of corrective actions to prevent recurrence.
- Provide technical input to Quality, Regulatory and Post-Market Surveillance teams to support the preparation of documentation and ensure compliance with applicable quality and regulatory requirements.
- Ensure the effectiveness and compliance of the complaint handling process in accordance with EU MDR 2017/745 and ISO 13485.
- Support CAPA investigations related to product quality issues identified through complaints.
- Support internal and external audits by preparing required documentation, addressing audit queries, and ensuring compliance with regulatory and quality standards.
Must Have
- Bachelor's or higher Degree in Biomedical Engineering/Life Sciences/Pharmacy
- 3-5 years of experience in complaint Handling, post-market surveillance, or vigilance within the medical device or healthcare industry.
- Basic understanding of ISO 13485, EU MDR 2017/745, and other applicable global regulatory 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, analyse and organise data, prepare clear presentations, and manage communication and scheduling effectively.
- Strong Business Acumen and organisational skills: Ensures accuracy and compliance in statistical data analysis and manages multiple tasks efficiently.
Good to Have
- Certification in complaint handling/MDR 2017/745 and ISO 13485.
- Experience with complaint handling systems, QAD, EtQ Reliance, or any other QMS software.
- Experience with Tableau, Power BI, or any other visualisation tool.
- Familiarity with complaint reporting to regulatory authorities
- Ability to work independently and in a global team environment.
Working Hours:
10.30 am to 7.30 pm
