Senior Manufacturing Quality Engineer

Smith+Nephew•Mansfield, MA

1d•$96,750 - $145,000•Hybrid

About The Position

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Step into a senior level role where your expertise will directly influence product quality and patient outcomes. As a Senior Manufacturing Quality Engineer, you will play a key role in strengthening manufacturing processes, ensuring compliance, and driving continuous improvement in a highly regulated medical device environment. Based in Mansfield, MA, this is an exciting opportunity to collaborate cross functionally and make a lasting impact.

Requirements

Bachelor’s degree in Engineering such as Mechanical, Biomedical, Industrial, or a related discipline
3 to 5 years of experience in quality engineering within a manufacturing environment
Experience working in a regulated industry
Strong understanding of quality systems, risk management, and statistical analysis

Responsibilities

Lead nonconformance management and CAPA activities, including root cause investigations and implementation of corrective and preventive actions
Partner with manufacturing and operations teams to enhance process robustness and reduce variation and defect rates
Ensure compliance with applicable regulatory and quality standards including ISO 13485, FDA 21 CFR Part 820, and ISO 14971
Drive continuous improvement initiatives using risk based methodologies such as PFMEA
Support development of inspection strategies including measurement system analysis
Perform data analysis using statistical tools to evaluate and improve process capability
Support process validation activities including IQ, OQ, and PQ