If you are a Quality Engineer with experience within Medical Devices arena, please read on!
-We are an established (20+ years) and growing, elite Design firm specializing in a variety of consumer and medical technology products.
-Location: Beverly, MA area
-Base salary is DOE, with career growth, great people, hot products and technologies! We have reat benefits as well!
-Best candidates have manufacturing, medical device and regulatory experience.
-Define and determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
-Identify sample size and acceptable errors and determining levels of confidence.
-Develop experiments by applying full and fractional factorial techniques.
-Develop sampling plans via variable, and sequential sampling methods.
-Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
-Report generation by collecting, analyzing, and summarizing data; and making recommendations.
-Maintains statistical process controls. example, demerit/unit, zone charting, for distributions and individual-medial/range for multi-stream processes.
-Attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, participating in professional societies, and maintaining ASQ-certified quality engineer qualification.
-Ensures products adhere to company and industry quality standards
-Bachelor's degree in engineering or equivalent discipline / equivalent work experience.
-Hands-on working knowledge of the FDA QSR and ISO 13485 required.
-Test methods and standards for the design, verification, and validation of medical device products.
-Manufacturing environment preferred.
-Risk management, and risk assessment techniques, such as FMEA, fault tree analysis, 5 Why's, and etc..
-Root cause analysis experience
-Development of inspection and work instructions.
-Part inspection, including layout, in process, final, and receiving using all types of mechanical inspection.
-Preparation of inspection reports.
-Coordination and performance of internal process/product audits.
-Performance process capability studies.
Preferred:
-Programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and gauging R&R studies.
-CAD Data Analysis (measurement & manipulation).
We're setting up interviews now!
Please FULLY COMPLETE THE APPLICATION QUESTIONS INCLUDING THE SELF ASSESSMENT ASAP! Complete applications will receive priority! We'd like to get you set up for an interview ASAP if you'd like this opportunity and are a suitable candidate! There are 4 short questions. Should take you no more than 4-8 min max!
1. Apply directly to this job opening here!
Or
2. E-mail directly for more information to Alex.Breslin@cybercoders.com
Direct FT perm position with growing company!
Full benefit package!
Benefits
-We are an established (20+ years) and growing, elite Design firm specializing in a variety of consumer and medical technology products.
-Location: Can be based out of either Beverly, MA area
-Base salary $95K-$125K and DOE, with career growth, great people, hot products and technologies!
-Best candidates have manufacturing, medical device and regulatory experience.
-Define and determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
-Identify sample size and acceptable errors and determining levels of confidence.
-Develop experiments by applying full and fractional factorial techniques.
-Develop sampling plans via variable, and sequential sampling methods.
-Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
-Report generation by collecting, analyzing, and summarizing data; and making recommendations.
-Maintains statistical process controls. example, demerit/unit, zone charting, for distributions and individual-medial/range for multi-stream processes.
-Attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, participating in professional societies, and maintaining ASQ-certified quality engineer qualification.
-Ensures products adhere to company and industry quality standards
-Bachelor's degree in engineering or equivalent discipline / equivalent work experience.
-5 years minimum hands-on working knowledge of the FDA QSR and ISO 13485 required.
-Test methods and standards for the design, verification, and validation of medical device products.
-5+ years in a manufacturing environment preferred.
-Risk management, and risk assessment techniques, such as FMEA, fault tree analysis, 5 Why's, and etc..
-Root cause analysis experience
-Development of inspection and work instructions.
-Part inspection, including layout, in process, final, and receiving using all types of mechanical inspection.
-Preparation of inspection reports.
-Coordination and performance of internal process/product audits.
-Performance process capability studies.
Preferred:
-Programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and gauging R&R studies.
-CAD Data Analysis (measurement & manipulation).
We're setting up interviews now!
Please FULLY COMPLETE THE APPLICATION QUESTIONS INCLUDING THE SELF ASSESSMENT ASAP! Complete applications will receive priority! We'd like to get you set up for an interview ASAP if you'd like this opportunity and are a suitable candidate! There are 4 short questions. Should take you no more than 4-8 min max!
1. Apply directly to this job opening here!
Or
2. E-mail directly for more information to Alex.Breslin@cybercoders.com
Direct FT perm position with growing company!
Full benefit package!
So, if you are a Senior Quality Engineer with experience, please apply today!
Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Lynne Azkoul-Polanis
Applicants must be authorized to work in the U.S.
Lynne Azkoul-Polanis is recruiting for this position and the positions below.
Email me to apply for this position
Employees will receive paid leave to the extent required by state or local law
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.