Supplier Quality Engineer

Job Summary

Job Description Job title: Supplier Quality Engineer Role reports to: Senior Supplier Quality Manager in Europe and QRA Manager in India.

Purpose The Supplier Quality Engineer is responsible for managing and improving supplier quality across multiple sites in EMEA. This role ensures Medline International EMEA suppliers comply with quality standards, regulatory requirements, and organizational expectations while supporting supplier development and driving continuous improvement. The Supplier Quality Engineer will collaborate with internal stakeholders and external partners to deliver exceptional product quality and minimize risk.

Activities & Responsibilities

• Supplier Management and Oversight

• Oversee and monitor the quality performance of multiple suppliers across Asia and EMEA;
• Develop and maintain strong relationships with suppliers to ensure alignment on quality and operational goals;
• Review the supplier quality audits and assessments to ensure compliance with company standards, ISO 13485, ISO 9001, MDR 2017/745 and customer requirements.

• Quality Assurance and Compliance

• Execute supplier quality management processes, including quality control plans in coordination with the QA team;
• Lead investigations (SCAR) into quality issues, working closely with suppliers to implement robust corrective and preventive actions (CAPA);
• Ensure suppliers adhere to ISO 13485, ISO 9001, MDR 2017/745, or other applicable international standards and regulations.

• Collaboration and Cross-Functional Support

• Work closely with internal teams, including Purchasing, Quality & Regulatory, and Operations to ensure supplier quality aligns with business goals;
• Act as the primary quality contact for suppliers, facilitating communication and issue resolution;
• Partner with the Division to qualify new suppliers and manage supplier transitions where necessary;
• Work closely with the stakeholders and colleagues at Medline GSO.

• Reporting and Data Analysis

• Maintain accurate records of supplier evaluation, performance, audits, and corrective actions.
• Provide regular reports on supplier quality metrics, trends, and risks to senior management.
• Utilize data analysis to identify systemic issues and implement strategic solutions.

• Continuous Improvement

• Identify opportunities for process improvements and drive initiatives to enhance the efficiency and effectiveness of the QMS.

• Participate in cross-functional teams to implement best practices in quality management.

• Drive continuous improvement initiatives with suppliers to enhance product quality, reduce non-conformances, and optimize supplier processes.

• Collaborate with suppliers to implement process improvement methodologies.

• Monitor supplier KPIs such as CPM, audit results, complaints, and inspection results.

Job Requirements

• Bachelor's degree in Engineering, Supply Chain Management, or a related field (a Master’s degree is a plus); • Minimum of 5+ years of experience in Supplier Quality Management, ideally within a global manufacturing or supply chain environment, particularly in the Medical Device industry; • Strong knowledge of Supplier Quality Management processes and quality standards • Proficiency in data analysis and reporting tools such as Excel and Power BI; • Excellent skills in auditing and problem-solving; • Strong communication, negotiation, and influencing skills; • In depth knowledge and training on ISO 9001, ISO 13485 and MDR 2017/745 is required; Preferred Qualifications • Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or equivalent qualifications • Lead Auditor Certification for ISO 13485; • Proven ability to manage multiple/large suppliers across diverse geographical locations; • Project management skills with the ability to effectively drive results. 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.