Senior Supplier Quality Engineer

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

The Senior Supplier Quality Engineer is responsible for quality engineering and management activities with suppliers driving quality improvement, ensuring compliance, and supporting Value Add Value Engineering (VAVE) / Expansion project activities. The Supplier Quality Engineer will also assist in maturing Supplier Quality processes and partnering with suppliers to drive proactive and systematic improvements.

This position is part of the Supplier Quality Engineering department and will be located in Bangalore, India with expectation to work onsite five days per week. The position will report directly to Quality in India with dotted line to Supplier Quality in the US. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Execute supplier quality compliance activities including supplier process audits, supplier assessments, supplier risk classifications, supplier corrective action processes (SCAR), supplier onboarding, and supplier evaluations
• Apply manufacturing quality engineering toolsets including NCR, SCAR, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification and validation plans, validation protocol development, Cpk/PpK, SPC, DOE, incoming inspection plans, inspection methods, process data analysis, and DMAIC
• Manage supplier quality issues, supplier changes, supplier quality agreements, and supplier-driven initiatives across assigned product lines
• Lead Quality Engineering deliverables for NPI and Sustaining projects, ensuring DHF and DMR compliance with company procedures and regulatory requirements
• Provide engineering analyses and quality oversight to ensure product and process compliance with applicable manufacturing, validation, and regulatory standards

The essential requirements of the job include:

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Material Science Engineering or similar scientific discipline field with 5+ years of related work experience OR Master's degree with 3+ years of related work experience
• Develop and understand the application of production and process controls including process validation, process control plans and statistical process control utilizing best practice and innovation.
• Utilization and application of Statistical methods for computing and analyzing data and driving measures and actions for improvement.
• Background in New Product Introduction, Manufacturing Process and Quality System improvements working in a Team Environment utilizing best practices and innovation.
• History developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry with stringent quality regulations.

It would be a plus if you also possess previous experience in:

• FDA / GMP 21CFR820
• ISO 13485
• Certified Lead Auditor
• Instrument Box Level, Injection Molding, and/or other Material Consumable experience

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.