Company:
Our Client (A global health and wellness company, more than 20 years in the market.)

Position Summary

This is a critical, high-impact, individual contributor role responsible for
spearheading and maintaining all Quality Assurance (QA) systems and regulatory compliance
for our client's innovative health and wellness products, within the Malaysian and SEA markets.

The Engineer serves as the local QA expert, ensuring continuous compliance with
ISO 9001
(as the core system), GDPMD, and local registration requirements for
Medical Devices, Food Supplements, Pharmaceuticals, and Cosmetics
. This role is ideal for a proactive, self-motivated professional with strong commercial quality experience in the medical or healthcare industry.

Key Responsibilities & Expectations

1. QA System Maintenance & Audits (Spearhead Role)

• 
  QMS Integrity:
  Act as the
  spearhead
  for the local Quality Management System (QMS), ensuring continuous maintenance and compliance with
  ISO 9001
  and other relevant standards (e.g.,
  ISO 13485, GDPMD, EU GMP
  ).

• 
  ISO Audits:
  Plan, prepare for, and participate in internal/external
  ISO audits
  . Manage the control room setup, audit readiness throughout the business, and all required post-audit follow-up actions.

• 
  Process Enhancement:
  Drive and support quality improvement projects to enhance overall performance and maintain robust QA processes and regulations.

2. Regulatory Compliance & Product Registration

• 
  Product Registration:
  Manage the
  registration of new products
  and maintain all existing product registration records and files for Medical Devices (specifically in Malaysia), Food Supplements, Pharmaceuticals, and Cosmetics.

• 
  Authority Liaison:
  Serve as the primary point of contact and liaise with all relevant competent authorities regarding product regulations in the territories.

• 
  Design Support:
  Actively support all product design activities from initiation through full product release, ensuring compliance with all regulatory requirements.

• 
  Post-Market Surveillance:
  Advise on the requirements for post-market surveillance (PMS) according to relevant QMS/ISO systems.

3. Documentation & Collaboration

• 
  Documentation Control:
  Manage the document change order (DCO) process for both internal teams and contract distribution organizations.

• 
  Training:
  Develop and deliver key training programs to enhance quality and regulatory awareness across the Business Unit.

• 
  Vendor & Facility Support:
  Support and manage vendors and distribution partners as required.

Requirements

Candidate Requirements

Education & Experience

• 
  A relevant Degree qualification combined with
  3 to 5 years of demonstrated work experience
  in administering regulatory and/or Quality Systems.

• 
  Crucial:
  Proven experience in
  commercial quality
  from the
  Medical Device, Pharmaceutical, or Cosmetic
  industry sectors, with a demonstrated ability to handle a variety of quality processes.

Hard Requirements & Expertise

• 
  QMS Expertise:
  Mandatory, thorough working knowledge of
  ISO 9001
  .

• 
  Product Scope:
  Direct experience with regulatory requirements for Medical Devices, Food Supplements, Pharmaceuticals, or Cosmetics.

• 
  Language:
  Strong command of the English language
  (written and verbal) is crucial for liaising with regional teams and authorities.

Soft Skills & Work Style

• 
  Independence:
  Highly self-motivated and able to work effectively as the sole QA resource in Malaysia.

• 
  Collaboration:
  Strong communication skills and demonstrated ability to collaborate effectively across functional lines (including the Regional QA team).

• 
  Agility:
  Detail-oriented, able to organize and prioritise multiple tasks effectively in a fast-paced environment.

• 
  Travel:
  Willingness to travel as and when required between the Malaysia and Philippines facilities.