Quality Assurance Engineer

Work on life saving medical devices
Join a growing team

About Our Client

Our client has over 40 years of experience leading the development and manufacturing of innovative medical devices designed for minimally invasive surgical procedures. Their solutions support a range of specialties, including urology, gastroenterology, laparoscopy, and endoscopy, with a strong focus on enhancing patient outcomes, improving surgical efficiency, and ensuring safety. They are currently seeking a skilled Quality Assurance Engineer to join 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

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

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