Senior Quality Lead — Validation & Projects

Bard Sdn Bhd

Kulim

On-site

MYR 120,000 - 180,000

Full time

8 days ago

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Bard Sdn Bhd is seeking a Senior Quality Engineer (Validation & Project) to lead change control and drive site validation programs in a regulated manufacturing environment. You will develop validation protocols, manage PFMEA, and provide quality leadership across cross‑functional projects.

You will oversee IQ/OQ/PQ activities, apply statistical analysis to process capability, and ensure compliance with ISO 13485, FDA/ISO GMP standards.

Qualifications

Bachelor's degree in Engineering, Science, Quality, or related discipline.
5+ years of experience in Quality Engineering, Validation, or regulated manufacturing.
Experience in Process Validation (IQ/OQ/PQ) and lifecycle management.
Strong PFMEA, risk management, change control systems knowledge.
Familiarity with QMS and electronic quality systems.

Responsibilities

Lead site change control processes and assess quality impact of changes.
Plan, execute, and oversee validation activities (IQ/OQ/PQ, Process Validation).
Develop and review validation protocols, reports, and PFMEA.
Provide quality oversight for new equipment/material/Product introductions (NPI).
Analyze process and validation data; use statistical methods for decision making.
Lead RCA, CAPA and risk management activities.
Monitor quality performance and drive continuous improvement.
Support audits and regulatory inspections.