Senior Supplier Quality Engineer (Medical Devices)

Location: Penang, Malaysia; hybrid arrangement with part-time work at the company location and part-time remote work from home.

Company

hirify.global is a global life sciences, diagnostics, and biotechnology organization operating through companies including Cepheid and Pall Corporation.

What you will do

• Establish supplier quality compliance initiatives, including process audits, assessments, risk classification, corrective actions, onboarding, and evaluations.
• Define and apply manufacturing quality tools such as NCR, SCAR, MRB, PFMEA, process validation, control plans, SPC, DOE, Cpk/PpK, and DMAIC problem solving.
• Collaborate with product support, engineering, and other teams to resolve supplier quality issues and manage supplier changes and quality agreements.
• Represent and lead Quality in new product introduction and sustaining projects.
• Ensure engineering and scientific analyses are defensible and that DHF/DMR documentation complies with company policies and governmental regulations.

Requirements

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Material Science Engineering, or a similar scientific discipline with 5+ years of related experience; or a master’s degree with 3+ years of related experience.
• Experience developing and applying production and process controls, including process validation, process control plans, and statistical process control.
• Experience using statistical methods to analyze data and drive improvement actions.
• Background in new product introduction, manufacturing processes, and quality system improvement in a team environment.
• Experience developing business processes and quality systems from product design through manufacturing in a mature, highly regulated industry.

Nice to have

• Experience with FDA/GMP 21 CFR 820 or ISO 13485.
• Certified Lead Auditor qualification.
• Experience with instrument box-level products, injection molding, or other material consumables.

Culture & Benefits

• Flexible hybrid working arrangement for eligible roles.
• Healthcare programs and paid time off.
• Career growth and development opportunities within a life sciences and diagnostics organization.
• Continuous improvement culture based on the hirify.global Business System.