Quality Engineer II (Validation, NCR, CAPA)-Medical Device

Smith & Nephew - Mansfield, MA (30+ days ago)3.7


The Quality Engineer II is responsible for supporting the Smith & Nephew Quality Management Systems. The Senior 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 the Federal Food, Drug, and Cosmetic Act (the act).


Support and/or implement quality planning techniques in a medical design/manufacturing environment for new product introductions;

Drive the use of statistical and risk management techniques for design and manufacturing and medical device industries;

Participate in Design Reviews and identify improvements based on relevant risk analysis, past manufacturing experience, and Marketing/Customers’ specifications/requirements for products;

Establish and participate in supplier qualification/development activities to ensure that products meet design and manufacturing requirements as part of Design Transfer;

Implement protocols and methods (including SOP’s) to ensure that incoming material and manufactured products are compliant with internal requirements as well as to standards/regulations for worldwide distribution;

Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.

Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement;

Support cross-functional teams in the execution and reporting of quality improvement projects with a focus on overall process improvements, scrap reduction and Supplier Quality improvement;

Drive corrective, preventive, and closure actions for project issues related to quality and/or test nonconformance;

Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements;

May 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.




Bachelor's degree in Engineering.



Quality Engineer / Design Assurance Engineer:
Minimum 2 year in engineering, preferably in Medical Device / Biologics/ IVD manufacturing experience.

Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485.