Job Description

Position : Quality Assurance Engineer

Salary Range : Up to RM 6,500

Location : Bangsar South, KL

Working Hours : 9.30am - 6.30pm (Monday - Friday)

RESPONSIBILITIES

Support the establishment, implementation, and continuous improvement of the Business Unit (BU)

Quality Management System (QMS)

, ensuring compliance with applicable quality standards, regulatory directives, and global regulations. Ensure site and partner compliance with corporate quality policies, procedures, and regulatory requirements. Maintain and manage regulatory registration records for all existing products across assigned territories, including

Medical Devices, Food Supplements, and Cosmetic products

. Liaise with regulatory authorities, notified bodies, and registration agencies on matters related to product registrations, renewals, and regulatory compliance. Assist in maintaining and updating quality systems to align with evolving regulatory requirements and industry best practices on a global basis. Develop, coordinate, and deliver quality and regulatory training programs to internal teams and contract facilities to enhance compliance awareness. Coordinate with BU facilities to track product registration status and ensure fulfillment of ongoing regulatory obligations. Manage and control document change orders for internal teams and external contract manufacturers or distributors. Actively support design and development activities from project initiation through product release, ensuring compliance with applicable regulatory and quality requirements. Participate in internal and external audits, including audit preparation, execution support, audit hosting, follow-up actions, and audit readiness activities. Provide guidance on

post-market surveillance

requirements and ensure alignment with QMS and ISO standards. Drive, participate in, and support continuous quality improvement initiatives and risk-based quality projects. Compile and analyze quality data for

management reviews

and key performance indicators. Support and manage external vendors and contract partners to ensure compliance with quality and regulatory requirements. Perform additional duties and quality-related responsibilities as assigned.

REQUIREMENTS

Bachelor's Degree in

Pharmaceutical Sciences, Life Sciences, Engineering

, or a related discipline, with

3-5 years of relevant experience

in regulatory affairs and/or quality system administration; an equivalent combination of education and experience may be considered. Strong working knowledge of

ISO 9001, ISO 13485, GDPMD

, and/or

EU GMP

quality systems is essential. Prior

auditing experience

against ISO 9001, ISO 13485, GDPMD, and/or EU GMP standards is highly preferred. Excellent command of the

English language

, both written and verbal. Strong technical aptitude with effective communication, teamwork, and problem-solving skills. Ability to work efficiently in a

fast-paced, regulated environment

while managing multiple priorities. Highly organized, detail-oriented, and self-motivated with strong time management skills. Demonstrated ability to collaborate across functional teams and contribute effectively within a commercial quality organization. Capable of working independently on assigned projects while coordinating with multiple departments simultaneously. Willingness to

travel as required

to support audits, suppliers, and operational sites.
Job Types: Full-time, Permanent

Pay: RM3,500.00 - RM6,500.00 per month

Benefits:

Dental insurance Health insurance Maternity leave Opportunities for promotion Parental leave Professional development Vision insurance
Education:

Bachelor's (Preferred)
Experience:

QA/QC: 1 year (Preferred)
License/Certification:

ISO 13485 (Preferred) ISO 9001 (Preferred)
Work Location: In person