Manufacturing Quality Engineer 2

Smith+Nephew•Mansfield, MA

1d•$74,250 - $111,500•Hybrid

About The Position

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about driving quality excellence in a fast-paced manufacturing environment? As a Manufacturing Quality Engineer II, you will play a key role in ensuring our products meet the highest standards of compliance and performance, while contributing to continuous improvement initiatives that directly impact patient outcomes. This is an exciting opportunity to grow your career in a collaborative and purpose driven environment where your expertise truly makes a difference.

Requirements

Bachelor’s degree in Engineering such as Mechanical, Biomedical, Industrial, or a related discipline
1 to 3 years of experience in quality engineering within a manufacturing environment
Experience working in a regulated industry
Strong understanding of quality standards and regulations including ISO 13485 and FDA 21 CFR Part 820
Ability to apply statistical analysis and quality engineering principles to solve problems and drive improvements

Responsibilities

Supporting and improving product and process quality across manufacturing operations
Leading and supporting nonconformance investigations and CAPA activities, including root cause analysis and implementation of corrective actions
Partnering with manufacturing and operations teams to strengthen process robustness and reduce variation and defects
Applying risk-based thinking using tools such as PFMEA to identify and mitigate process risks
Developing and optimizing inspection strategies, including measurement system analysis
Performing data analysis using statistical tools such as control charts and capability analysis
Supporting process validation activities including IQ, OQ, and PQ