QUALITY ASSURANCE ENGINEER 3
Apply NowCompany: Della Infotech, Inc.
Location: Durham, NC 27713
Description:
Job Description:
Problem Solving
o Run complex problem solving efforts without oversight, and mentor others on best practices. Use advanced Six Sigma tools. Introduce and drive the adoption of new tools and methods to the business. Apply strong analytic skills as proven by track record of analyzing and fixing complex problems.
Engineering
o Understand Design Controls, Change Controls, Product Engineering processes, and Production process control methodologies in a medical device environment.
Quality Systems & Risk Management
o Navigates quality system independent of oversight. Develops project plans including the proposed quality system risks & benefits. Makes updates to improve quality systems and mentor others. Analyzes RMAs, QNs and make the necessary updates to risk documents.
Compliance
o Able to articulate the latest and complex regulation to project team. Able to understand the impact of regulations to our procedures and make the corresponding SOP/DOP updates. Able to contribute in external audits, perform internal audits.
Ability to influence others
Passionate about our mission to improve product quality. Able to use persuasive, logical arguments based on data. Assist people in finding creative compliant solutions which meet constraints. Lead by example
A passion for doing the vital few things efficiently and well
A strong desire to make work fun
Skills, Experience, Education, & Training:
Minimum Education- Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
Technical Expertise: 5+ years' experience in Quality Engineering or related field, with at least 3 year in medical device manufacturing:
Problem Solving
o Run complex problem solving efforts without oversight, and mentor others on best practices. Use advanced Six Sigma tools. Introduce and drive the adoption of new tools and methods to the business. Apply strong analytic skills as proven by track record of analyzing and fixing complex problems.
Engineering
o Understand Design Controls, Change Controls, Product Engineering processes, and Production process control methodologies in a medical device environment.
Quality Systems & Risk Management
o Navigates quality system independent of oversight. Develops project plans including the proposed quality system risks & benefits. Makes updates to improve quality systems and mentor others. Analyzes RMAs, QNs and make the necessary updates to risk documents.
Compliance
o Able to articulate the latest and complex regulation to project team. Able to understand the impact of regulations to our procedures and make the corresponding SOP/DOP updates. Able to contribute in external audits, perform internal audits.
Ability to influence others
Passionate about our mission to improve product quality. Able to use persuasive, logical arguments based on data. Assist people in finding creative compliant solutions which meet constraints. Lead by example
A passion for doing the vital few things efficiently and well
A strong desire to make work fun
Skills, Experience, Education, & Training:
Minimum Education- Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
Technical Expertise: 5+ years' experience in Quality Engineering or related field, with at least 3 year in medical device manufacturing: