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 May 2023 – May 2024.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.The Senior QMS Associate is responsible for ensuring compliance with regulatory and quality standards by managing and improving the Quality Management System in Europe region. This role will drive internal and external audits, oversee change management processes, manage CAPA (Corrective and Preventive Actions) from initiation to closure, and lead remediation activities. The Senior Associate QMS will also play a key role in fostering a strong quality culture & problem-solving mindset across the organisation.
Key Responsibilities:
- Audit Management:
- Plan, coordinate, and execute internal audits in accordance with ISO and regulatory requirements.
- Support external audits by regulatory bodies and notified bodies, ensuring timely and effective responses to findings.
- Change Management:
- Administer and maintain the change control system to ensure controlled implementation of changes.
- Collaborate with cross-functional teams to assess impact and ensure compliance during change execution.
- CAPA Management:
- Drive the CAPA process from initiation through closure, ensuring timely and effective issue resolution.
- Lead CAPA remediation activities and verify the effectiveness of implemented actions.
- Quality Culture:
- Promote and embed a proactive quality mindset across all levels of the organisation.
- Conduct training and awareness sessions on QMS processes and compliance requirements.
- Continuous Improvement:
- Identify opportunities for process improvement within the QMS framework.
- Support implementation of best practices and digital tools to enhance system efficiency.
Must Have
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- Minimum 3–5 years of experience in Quality Management Systems within a regulated Med Tech industry.
- Strong knowledge of ISO 13485, EU MDR, and regulatory compliance requirements.
- Experience in audit management, CAPA processes, and change control systems.
- Demonstrates excellent communication skills, conveying 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.
Good to Have
- Ability to influence and drive quality culture across diverse teams.
- Certified Lead Auditor for ISO 13485: 2016 and Six Sigma certified.
- Excellent analytical and problem-solving skills.
Working Hours:
10.30 am to 7.30 pm
