Quality Engineer

Overview

On Site
Depends on Experience
Contract - W2
Contract - 6 Month(s)

Skills

Product Development
Medical Devices
CAPA
Quality

Job Details

Seeking a Sr. Quality Engineer to support new product development in a medical device environment. This role ensures compliance with regulatory and internal quality standards through validation, data analysis, and technical documentation.

Key Responsibilities:

  • Investigate quality issues (CAPA, non-conformances, audits)

  • Perform test method validation (TMV) and assess conformance

  • Analyze data using statistical methods (Gage R&R, control charts)

  • Support training materials and work instructions

  • Lead small projects and provide direction to technicians

Must-Have Skills:

  • Bachelor s in Engineering or Scientific field + 4 yrs experience (or Master s + 2 yrs)

  • Test Method Validation knowledge

  • Strong technical writing skills

  • Experience with Windchill PLM

  • Statistical analysis skills (Minitab a plus)

  • Medical device experience preferred (catheter/polymer is a big plus)

Bonus:

  • Opportunity to work on next-gen TAVAR platform

  • Exposure to advanced validation/statistics

  • High visibility across cross-functional teams

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.