Engineer 1, Quality System

Smith+Nephew

Batu Kawan, Penang, Malaysia
Onsite
Quality management system
Iso 13485
Fda qsr 21 cfr part 820
Smith+Nephew is seeking an Engineer 1 for their Quality System team in Batu Kawan, Penang, focusing on maintaining and implementing the Quality Management System (QMS) in compliance with medical device regulations. The ideal candidate will have a background in Quality Engineering and experience with ISO standards, along with strong communication and organizational skills

Job Summary

  • This 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.
  • 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.
  • The role also supports HSE, sustainability, and energy policies by preventing safety and health injuries, environmental pollution, and energy wastage.

Matching Summary

Match Score: 85

Smith+Nephew is seeking an Engineer 1 for their Quality System team in Batu Kawan, Penang, focusing on maintaining and implementing the Quality Management System (QMS) in compliance with medical device regulations. The ideal candidate will have a background in Quality Engineering and experience with ISO standards, along with strong communication and organizational skills.

Skills & Requirements

Must-have

  • Quality Management System
  • ISO 13485
  • FDA QSR 21 CFR Part 820
  • MDSAP
  • CAPA
  • audits
  • change control

Nice-to-have

  • continuous improvement
  • technical innovations
  • HSE policies
  • sustainability
  • energy policies

Key Requirements

  • Bachelor’s degree in Science, Engineering, Math, Business, or related fields
  • Minimum of three years’ experience in Quality Engineering, Quality Systems, Quality Assurance, and/or Regulatory Compliance
  • Internal auditing experience in ISO 13485, FDA QSR 21 CFR Part 820, and MDSAP
  • Proficiency in MS Word, Excel, PowerPoint, and Project

Work Rights

Not specified

Tailored Resume

Cover Letter