Quality Assurance Engineer
$95kMichael Page International Inc.
- Work on life saving medical devices
- Join a growing team
- 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
- Compensation up to $95,000 (DOE)
- 3 weeks of PTO
- Medical, dental, and vision
- Short term/long term disability
- Tuition reimbursement
Vacancy posted 5 days ago
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