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Senior QA Design Eng. - Devices and Medical Devices

Company: CyberCoders
Location: Beverly
Posted on: May 29, 2023

Job Description:

Senior QA Design Eng. - Devices and Medical Devices Apply Beverly, MA Full-time $95,000.00 - $130,000.00 Posted 04/10/2023 If you are a Senior Quality Assurance Design Engineer with experience, please read on! Top Reasons to Work with Us -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
-Hybrid working arrangements can be discussed.
-Base salary $95K-$125K and DOE, with career growth, great people, hot products and technologies!

-Best candidates have manufacturing, medical device and regulatory experience. What You Will Be Doing Responsible for:
-Various design quality engineering functions supporting product development on Medical Device development
-Risk Management
-Collaboration with development teams and through SW Development Life cycle
-Team guiding through : Design Controls, Design V&V, Submission Strategy, compliance to Quality Management System.
-Support at all stages of Product Develpment
-Work with PMS related to Design Controls
-Client interactions
-Sustaining and Continuous Improvements

-CAD analysis What You Need for this Position -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.

-5 years of Design Assurance, New Product Development, Design Quality Engineering or related medical device experience
-Strong experience with 21 CFR820, ISO 9001/ISO 13485 and the industry quality requirements associated with product design & development as well as product risk management (ISO 14971)

-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.

-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!


2. E-mail directly for more information to What's In It for You -Direct FT perm position with growing company!
-Full benefit package!
-Great people too! So, if you are a Senior Quality Engineer with experience, please apply today! Applicants must be authorized to work in the U.S. Additional ways to apply We'll share your profile. The job poster may use it for jobs with other companies. Learn More Job ID: LP1-1734001 CyberCoders, Inc is proud to be an Equal Opportunity EmployerAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.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. Copyright 1999 - 2023. CyberCoders, Inc. All rights reserved. CyberCoders is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), 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 email We will make a determination on your request for reasonable accommodation on a case-by-case basis. UnitedHealthcare creates and publishes the Transparency in Coverage -Machine-Readable Files -on behalf of CyberCoders.

Keywords: CyberCoders, Boston , Senior QA Design Eng. - Devices and Medical Devices, Engineering , Beverly, Massachusetts

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