Job Description

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 Q...

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