Supplier Quality Engineer

4 weeks ago

Pune, India Danaher Full time

#LI-VK1

Be part of something altogether life-changing 

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us â working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity â so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Supplier Quality Engineer for Cytiva is responsible for providing quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards.

This position is part of the Global Supplier Quality team located in Pune/Bengaluru and will be Hybrid in nature At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

In this role, you will have the opportunity to:

  • Ensure exceptional product quality for patient safety, customer value beyond expectations, regulatory assurance, and optimized cost of quality. Leading the supplier management activities related to Consumables/Upstream Bioprocess by collaborating with Engineering, Project Management, Business Development, and Sourcing teams on all activities required to effectively manage supplier quality requirements, supplier onboarding, and supplier development.
  • Primary areas of focus will be Supplier Change request process, supplier qualification, part/process qualification, supplier auditing, issue resolution and improving supplier quality performance through continuous improvement activities and quality plan implementation and be the Supplier Quality team expert around industrial process control hardware and commercial off-the-shelf software licensing and build our compliance management policies in this area.
  • Ensure supplier compliance to QMS and regulatory requirements through supplier monitoring process through collaborating with Suppliers and internal Stakeholders to drive Quality improvements that minimize the Costs of Quality and support implementation of Supplier/Engineering Changes, New Product Introductions and Transfers.
  • Develop and execute Corrective and Preventive Action plans with suppliers to resolve non-conformance issues, build, and implement Supplier Audit Plan and undertake supplier technical reviews when appropriate.

The essential requirements of the job include:

  • Effective problem solver with the skills to lead Root Cause investigations / CAPA plans and influence others cross-functional and an excellent communicator and collaborator who can influence at all levels of the organization.
  • Qualified auditor experience preferably in both on-site and remote/virtual environments with knowledge of quality critical aspects in industrial process control and how to verify and validate them through process qualification.
  • Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, and site level products/processes/ Lean experience preferred with experience in supplier quality engineering, quality assurance, quality engineering, manufacturing, or engineering, preferably in the biotech or pharmaceutical industries.
  • Earned a bachelorâs degree in engineering or technical field with experience in manufacturing, engineering or quality assurance.

â

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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