Job Description

Position : Quality Assurance Engineer

Salary Range : Up to RM 6,500

Location : Bangsar South, KL

Working Hours : Monday - Friday (9.00am - 6.00pm)

Job Responsibilities

Quality Management System Development

: Assist in establishing a Business Unit (BU) quality management system and ensure compliance with all relevant Quality Standards, Directives, and Regulations. Enforce adherence to corporate policies and procedures across all sites.

Product Registration Maintenance

: Manage and maintain records for the registration of all company products in various territories, including Medical Devices, Food Supplements, and Cosmetics.

Regulatory Liaison

: Act as the key point of contact with competent authorities and regulatory bodies regarding the registration and compliance of Medical Devices, Food Supplements, and Cosmetic products.

Quality System Compliance

: Support the maintenance and continual improvement of quality systems in accordance with changing regulatory requirements and industry best practices on a global scale.

Training & Awareness

: Develop and deliver training programs to improve quality and regulatory awareness across BU internal teams and contract facilities as required.

Registration Status Monitoring

: Coordinate with BU facilities to monitor the registration status of products and ensure ongoing compliance with regulatory requirements.

Document Control Management

: Oversee the document change order process for both internal and external distribution organizations to ensure proper documentation control and tracking.

Design Support

: Actively support product design activities from initiation to product release, ensuring full regulatory compliance.

Audit System Participation

: Participate in internal and external audits, assist in audit preparation, and manage the hosting of third-party audits. Provide audit training and ensure the business is audit-ready.

Post-Market Surveillance

: Advise on post-market surveillance requirements and ensure integration into the QMS/ISO system.

Quality Improvement Projects

: Lead or participate in quality improvement initiatives and activities, driving continuous enhancements across the business.

Management Reviews

: Compile data and support management reviews to assess and improve quality performance.

Vendor Support

: Support and manage vendors to ensure they meet quality and regulatory standards as required.

Other Duties

: Perform additional tasks as assigned to support the quality assurance and regulatory function.

Requirements

Relevant

Degree

in a related field (e.g., Engineering, Quality Assurance, Life Sciences) combined with

3 to 5 years of proven experience

in regulatory and quality systems administration. A combination of education and experience may also be considered. In-depth knowledge of

ISO 9001

,

ISO 13485

,

GDPMD

, and/or

EU GMP

is essential. Experience in auditing to the requirements of

ISO 9001

,

ISO 13485

,

GDPMD

, and

EU GMP

is preferred. Strong command of the

English language

is essential for communication with internal and external stakeholders. Strong technical understanding of quality systems. Excellent

communication

and

teamwork

abilities. Self-motivated with a keen

attention to detail

. Ability to

organize

and

prioritize

tasks efficiently in a fast-paced environment. Proactive approach with the ability to work

independently

and manage multiple projects simultaneously. Ability to work collaboratively with cross-functional teams. Willingness to travel as required to meet business needs.
Job Types: Full-time, Permanent

Pay: Up to RM6,500.00 per month

Benefits:

Health insurance Opportunities for promotion Professional development
Education:

Bachelor's (Preferred)
Experience:

ISO 13485: 1 year (Preferred)
Work Location: In person