Supplier Quality Engineer

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check outwww.careers.indegene.com What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it? We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers. We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you. If this excites you, then apply below. Position: Supplier Quality Lead / Associate Manager The Supplier Quality Lead will be responsible for ensuring that all external suppliers, contract manufacturers (CMOs), and service providers meet the company’s quality standards and regulatory requirements. This role requires in-depth expertise in ISO 15378 (Primary Packaging Materials for Medicinal Products), ISO 13485, FDA 21 CFR Part 820, and the EU MDR. The SQL will lead supplier qualification, audits, performance monitoring, and continuous improvement initiatives to support product quality and compliance. Responsibilities: Supplier Management & Qualification Lead qualification, approval, and periodic performance reviews of critical suppliers and CMOs. Develop and execute supplier management plans aligned with business objectives. Evaluate and approve components and materials for use in regulated products.Audits & Compliance Conduct supplier audits per ISO 15378, ISO 13485, FDA, and EU MDR standards. Maintain audit records and ensure timely closure of audit findings and SCARs. Support regulatory inspections and submissions with supplier-related documentation.Quality Systems & Documentation Develop and maintain supplier quality agreements in collaboration with Legal and Procurement. Ensure supplier documentation meets product-specific and regulatory requirements. Support incoming inspection strategies and sampling plans (AQL, ANSI, etc.). Risk & Change Management Lead supplier risk assessments and contribute to ISO 14971-compliant risk files. Partner with cross-functional teams to assess and approve supplier-driven changes. Drive root cause analysis and corrective actions for supplier non-conformances. Continuous Improvement & Strategy Monitor supplier KPIs and drive performance improvement initiatives Participate in supplier onboarding, training, and capability development Lead initiatives to enhance supplier engagement and long-term partnerships Support development of incoming inspection strategies and risk-based controls Champion digital tools and data analytics for supplier performance tracking Team Leadership & Collaboration Lead and mentor a team of supplier quality engineers and specialists Allocate resources and set priorities for supplier audits, SCARs, and quality initiatives Foster a culture of accountability, continuous improvement, and regulatory excellence Collaborate cross-functionally with R&D, Manufacturing, Regulatory, and Procurement Drive team performance through coaching, goal setting, and development plans Represent supplier quality in cross-functional meetings and strategic planningQualifications and Skills: Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline. (Master’s preferred) 7–10 years of relevant experience in Supplier Quality Engineering, preferably in the medical device or pharmaceutical industry. ASQ CQE or CSQP certification preferred Certified Lead Auditor (ISO 15378/13485) or equivalent audit experience Strong knowledge of ISO 15378, ISO 13485, ISO 14971, FDA 21 CFR Part 820, EU MDR Experience with international suppliers and global regulatory compliance Familiarity with implantable devices and sterilization processes preferred Proficient in statistical tools (Minitab, JMP) and ERP/QMS systems (SAP, D365, TrackWise, MasterControl) Excellent communication, negotiation, and problem-solving skillsEQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.