Engineer 2, Quality System

Smith & Nephew; Kampung Sekolah Simpang Ampat; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading medical technology firm in Malaysia is seeking an experienced Quality Management System professional. The role involves managing the QMS, ensuring compliance with standards related to medical devices, and leading quality audits. Candidates should have a Bachelor's degree in a relevant field and a minimum of three years of experience in Quality Engineering or Assurance. A Master’s degree and ISO 13485 certification are advantageous. This position supports safety and sustainability policies while minimizing travel requirements.

Qualifications

• Bachelor’s degree required, Master's preferred.
• Minimum three years of experience in Quality Engineering or related fields.
• Desirable experience in medical device manufacturing.

Responsibilities

• Maintain understanding of quality system regulations.
• Ensure ongoing QMS inspection readiness.
• Support HSE, sustainability, and energy policies.

Skills

Quality Engineering

Quality Systems

Regulatory Compliance

Internal Auditing

Proficiency in MS Office Suite

Education

Bachelor’s degree in Science, Engineering, Math, Business, or related fields

Master’s degree

ISO 13485 lead auditor certification

Job description

Life Unlimited. At Smith+Nehphew we design and manufacture technology that takes the limits off living

This role is responsible for operating the Quality Management System (QMS) and ensuring that it is maintained and implemented effectively. It coordinates the development and implementation of QMS processes and procedures, and leads and conducts quality audits.

Responsibilities

• The role maintains a strong understanding of quality system regulations and standards related to medical devices, including ISO 13485, FDA QSR 21 CFR Part 820, and MDSAP. This includes leading the creation, modification, and implementation of procedures, work instructions, and related documentation, and managing key processes such as CAPA, audits, change control, quality system training, document control, and quality performance/management reviews.
• The position ensures ongoing QMS inspection readiness by coordinating preparation for external inspections and audits, conducting training on QMS principles for relevant functional areas, and identifying opportunities for continuous improvement. It also facilitates technical innovations to enhance QMS effectiveness in alignment with business objectives and undertakes special projects as required.
• The role supports HSE, sustainability, and energy policies by preventing safety and health injuries, environmental pollution, and energy wastage; reporting HSE incidents and providing feedback to drive improvements; ensuring compliance with all HSE regulations and rules.

Qualifications

• Based in Batu Kawan, Penang; requires a Bachelor’s degree in Science, Engineering, Math, Business, or related fields, with a Master’s degree considered an advantage. ISO 13485 lead auditor certification is also desirable.
• Minimum three years’ experience in Quality Engineering, Quality Systems, Quality Assurance, and/or Regulatory Compliance within a regulated industry, with medical device manufacturing experience considered a plus. Internal auditing experience in ISO 13485, FDA QSR 21 CFR Part 820, and MDSAP is preferable. Proficiency in MS Word, Excel, PowerPoint, and Project (including critical path analysis and Gantt chart preparation) is an added advantage.
• Ability to prioritize and manage multiple responsibilities, communicate effectively across all organizational levels, and meet the physical demands of the role, with reasonable accommodations provided for individuals with disabilities. Travel requirements are minimal (<10%).

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