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