Quality Assurance Engineer

Quality Assurance Engineer

Our client has over 40 years of experience leading the development and manufacturing of innovative medical devices for minimally invasive procedures. Their products support areas such as urology, gastroenterology, laparoscopy, and endoscopy, enhancing patient outcomes, surgical efficiency, and safety. They are now looking to add a talented Quality Assurance Engineer to their team.

Job Description

• 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

The Successful Applicant

• Bachelor's degree in Engineering
• 3+ 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
• SPONSORSHIP NOT PROVIDED

What's on Offer

• Compensation up to $95,000 (DOE)
• 3 weeks of PTO
• Medical, dental, and vision
• Short term/long term disability
• Tuition reimbursement

Job Summary