Quality Manager — ISO 9001 & Manufacturing Excellence

PerkinElmer; Johor; On-site; MYR 180,000 - 240,000; Full time

Job summary

PerkinElmer Johor seeks an experienced Quality Manager to establish and maintain the QMS in a manufacturing environment, ensuring ISO 9001 compliance. This role leads QA/QC activities, CAPA, risk management, and audits while driving continuous improvement.

Responsibilities include overseeing inspections, product release, process validation, and site transfers. The QMR will interface with global QMS teams and ensure readiness for inspections and regulatory audits.

Qualifications

• Experience implementing ISO 9001 in manufacturing environments.
• Strong CAPA, root-cause analysis, and risk management skills.
• Lead and participate in internal and external audits.

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS) per ISO 9001 and regulatory requirements.
• Oversee in-process and final inspection, incoming quality control, and product release activities.
• Manage CAPA, nonconforming materials, and validation activities (IQ/OQ/PQ).
• Lead design-to-manufacturing transfers with risk assessments and DFMEA/PFMEA updates.
• Drive post-market surveillance and feedback integration into design/production controls.
• Provide team leadership and staff development within the quality group.
• Support regulatory and notified body audits and document preparation.

Skills

ISO 9001

CAPA

FMEA

QA/QC

Audits

Leadership

Education

Bachelor's degree in Engineering/Life Sciences

Master's degree preferred

Tools

eQMS

MS Office

Job description

PerkinElmer Johor seeks an experienced Quality Manager to establish and maintain the QMS in a manufacturing environment, ensuring ISO 9001 compliance. This role leads QA/QC activities, CAPA, risk management, and audits while driving continuous improvement.

Responsibilities include overseeing inspections, product release, process validation, and site transfers. The QMR will interface with global QMS teams and ensure readiness for inspections and regulatory audits.