Senior Supplier Quality Engineer - NPI & Compliance

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

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.