Quality Engineer II/III

ATL Technology, LLC•Maple Grove, MN

8d•Onsite

About The Position

The Quality Engineer will have a great aptitude for learning, be solution-driven, and able to focus on both internal and external customer requirements. In this position, you will have the opportunity to assist with the growth of our quality department while participating as a member in cross-functional and business teams in support of quality initiatives to improve and develop processes with the understanding of regulatory compliance requirements of ISO and the FDA. Based in our Maple Grove, MN office, the Quality Engineer will ensure the company meets regulatory obligations as well as deliver customer confidence through well-performing systems. They will participate as a member on the Quality team to improve the site Quality Management Systems (QMS), contribute to audits, and navigate the QMS system to effectively answer questions. They will also participate as a member of various cross-functional teams to address Corrective and Preventive Actions (CAPA) and review the site CAPA process. In addition, they will address quality activities in a Medical Device Contract Manufacturing environment and participate as a member of the continual improvement team. The Quality Engineer will assure consistency of the Product Inspection methods and criteria across the enterprise leveraging statistical techniques and Measurement Systems Analysis and participate as a member of the Non-Conforming Material Report & Material Review Board process to assure the segregation of suspect materials and the timely assignment of corrective actions and tracking of results. They will also be able to demonstrate active management of a methodical approach to ensure tasks are completed.

Requirements

Bachelors in a technical / scientific discipline such as Manufacturing, Mechanical Engineering, Electrical Engineering, Physics, or similar technical degree or a combination of equivalent education and experience
At least 4 years of professional experience in a regulated industry
Clear understanding of the elements of ISO 13485 QMS processes and USA FDA part 820 regulations
Strong interpersonal and team building skills
Experience preparing for and hosting customer and regulatory audits and inspections

Nice To Haves

ASQ Certifications in Quality Engineering or Auditing
ISO 13485/9001 lead auditor
Six Sigma Black or Green Belt

Responsibilities

Ensure the company meets regulatory obligations
Deliver Customer confidence thru well performing systems
Participate as a member on Quality team to improve the site Quality Management Systems (QMS)
Contribute to audits and navigate the QMS system to effectively answer questions
Participate as a member of various cross functional teams to address Corrective and Preventive Corrective Actions
Review site CAPA process
Address quality activities in Medical Device Contract Manufacturing environment
Participate as a member of the continual improvement team
Assure consistency of the Product Inspection methods and criteria across the enterprise leveraging statistical techniques and Measurement Systems Analysis
Participate as a member of the Non-Conforming Material Report & Material Review Board process to assure the segregation of suspect materials and the timely assignment of corrective actions and tracking of results
Demonstrate active management of a methodical approach to ensure tasks are completed