CyberCoders Senior Electrical QA Engineer in Kalamazoo, Michigan
Senior Electrical QA Engineer Senior Electrical QA Engineer - Skills Required - PCBA Design, Manufacturing Processes, Quality Engineering, Medical Device Development, FDA / ISO regulations and standards, ASQ Certifications (CQE / CRE / CQM / CSSBB), Risk / Root Cause Analysis, GD&T, SPC, GHTF Approach to Validation
If you are a Senior Electrical Advanced Quality Engineer with experience in medical device development, please read on!
Based in Kalamazoo, MI - we are a fast growing medical technology company that works with doctors and hospitals providing value added tracking and life saving solutions as well as the world's leading efficiency devices for the operating room.
We are building and enhancing a suite of medical products that ensure doctors are working in the most efficient, patient considered and precise ways during critical surgeries and our devices are used during many different procedures.
We are a medium sized team of quality engineers that are heavily involved in all facets of new product development. With a background in electrical design and manufacturing, this team member will have an increase focus on PCBA design and manufacturing, other electrical subsystems, and proficiency in verification test for electrical systems.
Top Reasons to Work with Us
Stable yet growing organization w/ great track record of growth and strong tenure and employee retention
Excellent health and medical benefits for individuals and families
Growing product that helps save lives and enable better care
Opportunity to work both independently and part of a larger team with various levels of responsibilities
What You Will Be Doing
Understand and improve electrical / PCBA manufacturing processes
Execute QA engineering work and provide input throughout new product development
Collaborate for process validation programs and verification test strategies
Lead risk analysis and develop mitigation strategies
Guide teams through the quality system to ensure products are developed in compliance of the FDA, ISO, and other regulatory bodies
Possibly act as a trainer for QA topics (statistics, process validation and equipment qualification, DOEs, etc.)
Execute supplier development activities surrounding the Production Part Approval Process
What You Need for this Position
Bachelor of Science degree (B.S.) in Electrical Engineering or Engineering related discipline
3+ years of experience in an Engineering/Manufacturing environment in a Quality Engineering role in a regulated environment
Experience with medical device development and manufacturing
Working knowledge of FDA, ISO, and other regulations and standards, e.g. ISO 13485, ISO 62366, and IEC 60601
Working knowledge of Risk Analysis, GD&T, SPC, Root Cause Analysis, Statistics and practical applications
Process validation experience; preferred knowledge of GHTF approach to validation
ASQ Certifications (CQE, CRE, CQM, CSSBB)
So, If you are a Senior Electrical Advanced Quality Engineer with experience developing medical devices, please apply today!
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, 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.
Senior Electrical QA Engineer MI-Kalamazoo CV5-1463967