QA Engineer - Med Device MFG

This is a fantastic Quality Assurance Engineer opportunity with a growing manufacturer of minimally invasive medical devices for surgical procedures.

• Join a growing team and organization!
• Work with critical medical devices for the betterment of humanity, * 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

• 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
• Exposure to ISO13485
• 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

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

My client has been an industry leader for 40+ years in manufacturing state of the art medical devices for minimally invasive surgical procedures. Their products and solutions support specialities such as urology, gastroenterology, laparoscopy, and endoscopy, helping improve patient outcomes, surgical efficiency, and safety; they are seeking a skilled Quality Assurance Engineer to join the team.