• Provide quality leadership to product support project teams as the quality engineering representative. Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established. Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.
• Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.
• Ensure compliance to product specific standards, c GMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD/EU MDR requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.
• Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier.
• Support continuous improvement activities (CCRs and/or PARs).
• Support Post Market Surveillance activities, Management Review, and audits/inspections.

• Education: Bachelor’s degree in engineering or related discipline
• Experience: No experience required -Some medical device or related regulated industry or internship will be valuable.
• Fluent spoken and written in English.

• Need to be able to make sound decisions with attention to details
• Understanding the impact of regulatory requirements (eg. GMP’s, ISO 13485, ISO 14971, and MDR) on Smith & Nephew’s products is necessary
• Must be able to provide and implement solutions to quality problems
• Ability to plan and schedule multiple projects and tasks
• Effective written/oral communication skills
• Team player
• MS Office, MS Excel, and Statistical software proficiency

• Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website (
  https://www.smith-nephew.com/
  )
• Your Future: Generous annual bonus, Save As You Earn share options.
• Work/Life Balance: Meal allowance, School Allowance, Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
• Flexibility: Hybrid Working Model (For most professional roles).
• Training: Hands-On, Team-Customised, Mentorship.