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 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
