Quality Assurance Engineer (Devices)

About the role

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.

Responsibilities

• 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
• Ensure 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

Requirements

• 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
• Minimum Required Skills: Ability to manage multiple, simultaneous projects and deadlines, 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

Qualifications

• Minimum Required Qualifications: Certified Quality Engineer, Knowledge of CAD design software

Skills

• Preferred Skills Or Knowledge: None specified

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

Pay

Competitive compensation

Schedule

In person - Elgin, IL