Senior Supplier Quality Engineer

Cepheid; Selangor; Hybrid; MYR 90,000 - 150,000; Full time

Benefits offered by this job

Hybrid work arrangement

Health benefits

Job summary

Cepheid, a Danaher operating company, seeks a Quality/Process Engineer to drive supplier quality initiatives, NCR/SCAR management, and robust QC methodologies. The role supports NPI and sustaining projects, ensuring DHF/DMR compliance while applying SPC, DOE, and DMAIC practices.

You will collaborate across engineering and product teams to enhance manufacturing controls, risk assessments, and quality systems in a hybrid work environment at Cepheid.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Material Science Engineering or similar discipline 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.

Responsibilities

• Establish needed quality compliance and proactive initiatives including supplier process audits and assessments, supplier risk classifications, supplier corrective action processes, supplier onboarding, and supplier evaluations.
• Define, and apply the manufacturing quality toolset including NCR, SCAR, Supplier Evaluations, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk/PpK, SPC, incoming inspection plans, inspection methods, DOE, process data analysis, and DMAIC/Problem Solving.
• Initiate and collaborate with product support teams, engineering and others of complex issues on supplier quality issues, supplier changes, supplier quality agreements, and other supplier initiatives. This includes to represent and lead Quality in NPI and Sustaining projects providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and DHF/DMR comply with company policies and governmental regulations.

Skills

Quality compliance

Supplier audits

NCR/SCAR

DMAIC

Process validation

Statistical methods

NPI

GMP 21CFR820

Measurement systems analysis

Cross-functional collaboration

Education

Bachelor's degree in Mechanical/Industrial/Biomedical/Material Science Engineering

Master's degree (advantageous)

Tools

SPC

DOE

PFMEA

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

In This Role, You Will Have The Opportunity To

• Establish needed quality compliance and proactive initiatives including supplier process audits and assessments, supplier risk classifications, supplier corrective action processes, supplier onboarding, and supplier evaluations.


• Define, and apply the manufacturing quality toolset including NCR, SCAR, Supplier Evaluations, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk/PpK, SPC, incoming inspection plans, inspection methods, DOE, process data analysis, and DMAIC/Problem Solving.


• Initiate and collaborate with product support teams, engineering and others of complex issues on supplier quality issues, supplier changes, supplier quality agreements, and other supplier initiatives. This includes to represent and lead Quality in NPI and Sustaining projects providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and DHF/DMR comply with company policies and governmental regulations.

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.

At Cepheid 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 of the time at the Company location identified above and part of the 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 Cepheid can provide.

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.