Senior Supplier Quality & Process Development Engineer

Randstad Malaysia; Kuala Lumpur; On-site; MYR 250,000 - 380,000; Full time

Job summary

Randstad Malaysia's client, a global leader in advanced medical technology, seeks a Senior Process Development Engineer (Supplier Quality) to own supplier quality, qualification, and CAPA activities across global suppliers.

You will bridge Design Engineering and manufacturing to ensure incoming materials and external processes meet ISO 13485, IATF 16949, and 21 CFR Part 820 standards, while leading 8D/DMAIC style investigations.

Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Manufacturing, Materials, Industrial, Chemical, Biomedical, or related discipline).
• Minimum of 9 years hands-on engineering experience in SQE, Process Development, or Component Engineering in a regulated manufacturing environment.
• Experience with ISO 13485 / ISO 9001 / IATF 16949 or 21 CFR Part 820 preferred.
• Strong data-driven root cause analysis and statistical methods (8D, DMAIC, SPC, Gage R&R, CpK, Minitab).

Responsibilities

• Supplier Evaluation & Onboarding: assess potential and new supplier candidates; provide technical leadership for component industrialization.
• Component Specification & Qualification: collaborate with Design Engineering; generate test protocols; monitor validation; approve components.
• Inspection Systems & Metrology: develop and validate inspection tools; establish incoming inspection procedures; train inspection personnel.
• Root Cause & Defect Analysis: lead investigations for non-conformances; formulate CAPA/SCAR dispositions with suppliers.
• Design for Manufacturability: review early design specs for manufacturability and yield optimization.
• Leadership & Team Mentorship: provide technical guidance to inspection and support teams.

Skills

Supplier Quality Engineering

Process Development

CAPA/SCAR

Statistical methods

Stakeholder management

Education

Bachelor's Degree in Engineering

Tools

SPC

Minitab

Gage R&R

CAPA system

Job description

Randstad Malaysia's client, a global leader in advanced medical technology, seeks a Senior Process Development Engineer (Supplier Quality) to own supplier quality, qualification, and CAPA activities across global suppliers.

You will bridge Design Engineering and manufacturing to ensure incoming materials and external processes meet ISO 13485, IATF 16949, and 21 CFR Part 820 standards, while leading 8D/DMAIC style investigations.