About Medline:
About Medline India:
Medline India was set up 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 of June 2025 – June 2026.We are an organisation 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 organisation 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 recognised 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.
- Our Pune, India location currently has an exciting opportunity for a Quality Engineering Specialist within the Medline UNITE Foot and Ankle Orthopaedics Division. This role plays a key part in upholding quality standards aligned with our strategic engineering objectives.
- As a Quality Engineer, you will provide essential quality support across a range of activities, including complaint investigations, routine product evaluations, product testing, and documentation. You will also assist in vendor qualification processes.
- In addition to supporting ongoing QA functions, this position contributes to both new product development and legacy engineering projects related to implantable foot and ankle products and accessories.
- 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 United States.
Key Responsibilities,
- Responsible for validation activities, including evaluation of supplier documents (Physical, chemical & biological, packaging/transportation/ageing studies) for missing information/documents and development of biological evaluation plan & report.
- Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations and to support Design Control and Risk Management activities.
- Contribute to the construction and completion of DHFs, DMRs, Development & maintenance of product specification and other quality & regulatory documentation as necessary.
- Assist in customer/sales force complaints and ensure that complaints.
- Run monthly or quarterly complaint trend reports per SOP.
- Create and maintain inspection procedures.
- Work with the Regulatory team to provide supporting information for technical documentation. Ensure compliance with applicable testing requirements associated with product lines and processes.
Additional Responsibilities Include,
- This position is responsible for maintaining quality levels and minimising defects and failure rates. Review of inspection reports if needed.
- Support Divisional Quality Engineers and Vigilance Teams on incidents (root cause analysis) and customer complaints investigation.
- Assist in other Quality and Regulatory areas as necessary to support goals and objectives (Supplier Change Control, Quality Systems, Quality Audits, etc.).
Must Have
- Degree or higher in B. Tech (Biomedical)/ B.E. (Mech)/ M. Pharm. (Quality Assurance).
- 5-to 7-year work experience within the Medical Device industry with a strong Quality background.
- Familiarity with 21 CFR Part 820 or ISO 13485 design requirements.
- Proficiency in ISO 14971, ISO 10993 & other relevant ISO standards.
- 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 attention to detail and organisational 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 in working with orthopaedic or implantable devices/ systems.
- Working exposure in the US regulatory environment.
- Experience with ETQ Reliance, SAP, and QAD platforms.
- Exposure to global quality systems and multi-country document management.
- Ability to work independently and in a global team environment.
- Proficiency in ISO 14971, ISO 10993 & other relevant ISO standards.
- Familiarity with CAPA management, Change management, and other quality activities.
Working Hours:
10.30 am to 7.30 pm – daylight saving11.30 am to 8.30 pm – non daylight saving
