Pharmaceutical : Quality Compliance Engineer [Job ID : 13164]

PERSOL; Selangor; On-site; MYR 150,000 - 200,000; Full time

Job summary

A staffing solutions company is hiring a Quality Compliance Engineer in Selangor, Malaysia. This role ensures compliance with regulatory standards and improves the Quality Management System. Candidates should possess a Bachelor’s degree in a relevant field and have 3–5 years' experience in a quality function. The position offers a 12-month contract with a competitive salary of RM4,500 – RM6,000.

Benefits

Medical coverage

Leave entitlement

Statutory contributions

Qualifications

• 3–5 years' experience in a Quality function is required.
• Strong analytical and problem-solving skills to interpret operational data.
• ISO 13485 or GDPMD auditor certification is preferred.

Responsibilities

• Implement, monitor, and improve the local QMS.
• Prepare, review, and update Standard Operating Procedures (SOPs).
• Support deployment of corporate policies into the local QMS.

Skills

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor’s degree in Science, Biology, Chemistry, or related field

Tools

Knowledge of ISO 9001:2015

Knowledge of ISO 13485:2016

Job description

Pharmaceutical : Quality Compliance Engineer [Job ID : 13164]

Job Title: Quality Compliance Engineer
Location: Ara Damansara, Petaling Jaya, Selangor
Employment Type: 12-month contract via PERSOL (renewable based on performance)
Working Hours: Monday – Friday, 8:00 AM – 5:00 PM
Salary: RM4,500 – RM6,000 + statutory contributions, leave entitlement, medical coverage

About the Role

Our client is seeking a Quality Engineer to ensure compliance, uphold high operational standards, and drive continuous improvement within the Quality Management System (QMS). This role plays a key part in aligning with corporate standards and healthcare regulatory requirements, while providing support in audits, CAPA management, and cross-functional collaboration.

Key Responsibilities

• Implement, monitor, and improve the local QMS.
• Prepare, review, and update Standard Operating Procedures (SOPs), ensuring compliance with corporate and regulatory requirements.
• Support the deployment of corporate policies into the local QMS.
• Provide regulatory/compliance guidance on operations, including customer complaints and supplier management.
• Participate in internal, external, supplier, and regulatory audits.
• Manage CAPA and Field Corrective Action (FCA) activities, ensuring timely closure and effectiveness.
• Conduct QMS compliance training for cross-functional teams.
• Support and contribute to quality improvement projects and initiatives.
• Act as the local point of contact for all quality compliance matters.

Key Requirements

• Bachelor’s degree in Science, Biology, Chemistry, or related field.
• Minimum 3–5 years’ experience in a Quality function.
• Strong analytical and problem-solving skills to interpret operational data.
• Solid knowledge of ISO 9001:2015, ISO 13485:2016, and/or GDP/GDPMD standards.
• ISO 13485 or GDPMD auditor certification preferred.
• Experience in project management is an added advantage.
• Interested candidates are encouraged to send their updated resume to: [emailprotected]

"Note: This job description is subject to change and includes the responsibilities and requirements described above."