Senior Supplier Quality Engineer

Danaher · Pall Corporation, Malaysia

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Role summary

Danaher seeks a Senior Supplier Quality Engineer to establish quality compliance initiatives, define manufacturing quality toolsets, and collaborate across teams on supplier quality issues for life-sciences diagnostic systems. The role involves supplier audits, process validation, and regulatory compliance in a matrix environment.

What they're looking for

Bachelor's degree in Mechanical, Industrial, Biomedical Engineering, or Material Science with 5+ years experience; or Master's degree with 3+ years experience
Proficiency in production and process controls, process validation, and statistical process control
Strong statistical analysis skills for data-driven process improvement and decision-making
Experience with New Product Introduction and quality system improvements in regulated manufacturing
Track record developing business processes and quality enhancements across product design and manufacturing phases
FDA/GMP 21CFR820 or ISO 13485 experience preferred
Certified Lead Auditor certification preferred

What you'll be doing

Establish and execute supplier quality compliance programs including audits, assessments, risk classifications, and corrective action processes
Apply manufacturing quality methodologies including NCR, SCAR, PFMEA, control plans, validation protocols, and statistical process control
Lead cross-functional collaboration on complex supplier quality issues, supplier changes, and quality agreements
Provide quality engineering support to New Product Introduction and sustaining projects with regulatory compliance oversight

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Date posted5 days ago

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