Engineer 2, Quality System

Engineer 2, Quality System
 

Life Unlimited. At Smith+Nephew 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.
 

What will you be doing?

• The role is responsible for maintaining 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, as well as 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. Additionally, it facilitates technical innovations to enhance QMS effectiveness in alignment with business objectives and undertakes special projects as required.
• The role also supports HSE, sustainability, and energy policies by preventing safety and health injuries, environmental pollution, and energy wastage. It requires reporting HSE incidents and providing feedback to drive improvements, ensuring compliance with all HSE regulations and rules.

What will you need to be successful?

• The role is based in Batu Kawan, Penang, and 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.
• Candidates should have a minimum of 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, will be an added advantage.
• The position requires the 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, at less than 10%.