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Engineer 1, Quality System
Life Unlimited. At Smith+Nephew we craft and manufacture technology that takes the limits off living.
This role is responsible for operating the Quality Management System (QMS) and ensuring it is maintained and implemented optimally. It involves coordinating the development and implementation of QMS processes and procedures, as well as leading and conducting quality audits.
What will you be doing?
The role requires a deep understanding of quality system regulations and standards related to medical devices, including ISO 13485, FDA QSR 21 CFR Part 820, and MDSAP. The candidate will own the creation, modification, and implementation of procedures, work instructions, and documentation while handling key processes like CAPA, audits, change control, and quality training.
This position is responsible for ensuring the Quality Management System (QMS) is always inspection-ready, including coordinating preparations for external inspections and audits. The role also involves identifying opportunities for continuous improvement in QMS processes, aligning improvements with overall quality and business objectives, and facilitating technical innovations.
In addition to QMS responsibilities, the candidate will be encouraged to comply with HSE policies, sustainability, and energy regulations.
What will you need to be successful?
A Bachelor’s degree in Science, Engineering, Math, Business, or a related field is preferred, with a Master’s degree considered an advantage. ISO 13485 Lead Auditor certification is a plus.
The ideal candidate should have at least 3 years of experience in Quality Engineering, Quality Systems, Quality Assurance, or Regulatory Compliance, ideally in a regulated industry like medical devices. Experience with internal auditing in ISO 13485, FDA QSR 21 CFR Part 820, or MDSAP is helpful. Proficiency in MS Word, Excel, PowerPoint, and MS Projects, especially for critical path analysis and Gantt charts, is also helpful.
The candidate must be able to prioritize and lead multiple tasks while optimally presenting potential issues across all levels of the organization. The role requires meeting physical demands that can be reasonably accommodated for individuals with disabilities. Travel requirements are minimal, at less than 10%.
You. Unlimited.
We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve.
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 and pension Schemes, Save As You Earn share options.
Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.
Flexibility: Hybrid Working Model (For most professional roles).
Training: Hands-On, Team-Customised, Mentorship
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