Role OverviewThe Quality Engineer leads technical quality engineering and validation activities, applying validation, design controls, risk management, and statistical methods to ensure products and processes meet regulatory and quality system requirements.
What You Will Do
Develop and execute validation protocols, prepare comprehensive validation reports, and analyze validation data to identify trends and areas for improvement.
Why It Might Be a Fit
The ideal candidate will have 2-5 years of quality experience in a regulated industry, preferably in medical devices, and be able to interpret and apply regulatory and quality system requirements.
Requirements
- Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering, or a closely related engineering field
- Typically 2–5 years of quality experience in a regulated industry, preferably in medical devices
- Quality Engineer certification or another relevant professional certification preferred
- Working knowledge of applicable medical device quality system requirements, ISO, GMP requirements, and relevant international standards
- Ability to independently interpret and apply regulatory, quality system, technical, and customer requirements and resolve complex quality issues using structured problem-solving
- Proficiency in statistical analysis and data interpretation, including practical applications of DOE, FMEA, capability analysis, and sampling methods
- Strong technical writing, project leadership, organization, and cross-functional communication skills
- Ability to understand product applications, specifications, functionality, assembly, manufacturing processes, and test methods
- Microsoft Office skills and the ability to quickly learn eQMS, ERP, and other business systems; experience with MasterControl, Oracle, or comparable systems preferred
Benefits
- Medical/dental/vision benefits
- 401K match
- Annual performance bonus
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