Smith & Nephew supports healthcare professionals in more than 100 countries in their daily efforts to improve the lives of their patients. We do this by taking a pioneering approach to the design of our advanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems.
We have leadership positions in:
Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders
Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
Sports Medicine - minimally invasive surgery of the joint
Trauma & Extremities - products that help repair broken bones
We have around 16,000 employees around the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN)
The Quality Engineer is responsible for supporting the Quality Management Systems at Plymouth West. The Quality Engineer will ensure that the Regulations, Standards and Guidelines are complied with ensuring that finished devices will be safe and effective and otherwise in compliance with applicable regulatory requirements.
Provide quality engineering floor support for production area to ensure production is able to expand capacity and volumes. Document, evaluate, and disposition any nonconformances associated with production.
Support receiving inspection and in process inspection personnel. Enable optimization of any inspection efficiencies. Document, evaluate, and disposition any nonconformances identified during inspection.
Document, evaluate, and record process validation protocols, testing, and reports for process optimization related to current production and future production of new designs.
Initiate, identify root cause, evaluate, and document corrective and preventive action following the Quality Management System requirements for CAPA.
Complete inspection and evaluation of finished products in pre-sterile quarantine, post-sterile quarantine, and finished goods kitting locations. Ensure full conformance to specification requirements.
Ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team.
Travel: Some travel required
Education: Bachelor's degree
Experience: Quality Engineering, Minimum 3-5 years in Medical Device / Biologics / IVD manufacturing experience. Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR and ISO 13485
Smith and Nephew is an Equal Opportunity/Affirmative Action Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by applicable law.
Smith & Nephew