We’re looking for a Quality Engineer for our Southwest Houston client!

DESCRIPTION OF YOUR DREAM JOB:

• Job Title: Quality Engineer
• Location: Southwest Houston
• Pay: $75-85K
• Hours: 8-5
• Duration: Direct Hire
• Description of Duties: We are currently assisting one of our premier clients with a search for a Quality Engineer. This position will interpret FDA, ISO and CSA regulations and develop company compliance that satisfies ISO 13485, the Canadian Medical Device Regulations, and the U.S. FDA cGMP/QSR. Maintain knowledge of current and emerging global regulatory requirements affecting the business and make decisions regarding actions necessary to obtain or maintain compliance with applicable regulations. Develop and maintain new employee quality orientation meeting compliance requirements according to FDA and ISO standards. Support systematic audits in relation to requirements found in ISO 13485 and the FDA Quality System Regulation. Responsible for addressing opportunities for improvement identified during audits. Initiate corrective actions as needed resulting from audits, complaints and other QMS processes or product discrepancies. Works with Quality Assurance Specialist to generate all required management review documents. Initiates complaints in SAP complaint handling system. Participates in product development teams and reviews appropriate design and development deliverables including plans, reports, risk management and design reviews associated with products. Approves content of all material change requests by evaluating the impact of the change to ensure requirements per the standing processes are met. Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to reduce cost and improve the quality of products and services.
• Requirements: 3+ years’ of experience in manufacturing environment; medical devices experience preferred. Bachelor's Degree in Life Sciences, Quality Engineering, Regulatory Affairs, or other discipline. Proficient in the use of Microsoft Excel (graphs, mathematical formulas, linked spreadsheets, importing and exporting) as well as MSWord and PowerPoint. Technical background sufficient to understand devices and medical procedures so that devices and procedures can be explained to FDA and other regulatory bodies. Ability to read and interpret regulatory/legal documents and determine the required compliance activities.

WHO WE ARE:

Carlton Staffing is a local staffing firm in Texas with over 40 years of experience! We have connections with numerous hiring managers throughout Houston, Dallas and Fort Worth. An application with us is an open application with our rock-star clients. Don't wait another minute! Let our knowledgeable staff assist you today, visit www.carltonstaffing.com.