Quality Assurance Engineer (Devices)

Benefits Medical, Dental, Vision and Prescription Coverage Paid Time Off 401k Retirement Plan with company match Short- and Long-Term Disability Insurance Life Insurance Paid Parental Leave Tuition Reimbursement Job Overview The Quality Assurance Engineer is part of a team responsible for ensuring Northgate Technologies medical devices meet the highest standards for quality, accuracy, operating functionality, and reliability. Working directly on quality assurance—establishing through objective evidence that the product meets the design requirements—this position will oversee quality for the overall solution functionality, design and manufacturing workflow. You will work among a team of engineers, technicians, developers and project managers for direction, support and collaboration. Establish Policies and Procedures Establish activities for the development, application and maintenance of quality standards for processes, finished devices, materials, and other products Develop standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as electrical and mechanical Develop sampling procedures, forms and instructions for recording, evaluating, and reporting quality and reliability data Develop methods and procedures for disposition of discrepant material and devise methods to assess cost and responsibility Collaborate with Regulatory Affairs to meet the requirements of the FDA and Medical Device Directive Manage CAPA program for areas of responsibility Provide Insight Ensures management representation, when required, at audits of the quality system Support Product Development and Manufacturing Directs workers engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability Organizes, writes and conducts training sessions on quality control activities Plans all required test fixtures and tools for the correctness of components and products Health and Safety Contribute to a safe work environment by complying with all federal & state laws, Northgate policies, procedures and OSHA, if applicable Minimum Required Education and Experience Bachelor’s degree in Engineering (Electrical Preferred) 5 years of experience in manufacturing/quality 2 years of work experience with regulated electro‑mechanical medical products in a manufacturing environment Ability to manage multiple, simultaneous projects and deadlines Ability to synthesize and document requirements Excellent written and verbal communication skills Must be able to work independently, in a team environment, and with cross‑functional teams Working knowledge of Statistical software package Minitab, InfinityQS, Microsoft Word and Excel Experience in internal auditing of Quality Management Systems Preferred Skills or Knowledge Certified Quality Engineer Knowledge of CAD design software Working Conditions Clean office environment Minimal travel, including international, as needed Job Type: Full-time Work Location: In person - Elgin, IL Northgate Technologies, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. As part of our recruitment process, we may use AI tools to screen applicants and assist in evaluating candidate qualifications. All final hiring decisions are made by our recruitment team. Applicants who may need help completing an application or require reasonable accommodations to participate in the hiring process should contact Human Resources by emailing View email address on click.appcast.io. When completing this application, you may exclude information regarding your race, color, creed, religion, sex, national origin, citizenship, age, disability, medical condition, marital or veteran status, or any other status protected by law. #J-18808-Ljbffr Northgate Technologies Inc.