Quality Engineer II/III at ATL Technology, LLC

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

23 May, 26

Salary

0.0

Posted On

22 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Learning Aptitude, Solution Driven, Customer Requirements Focus, Quality Initiatives, Regulatory Compliance, ISO, FDA, Quality Management Systems (QMS), Audits, Corrective and Preventive Corrective Actions (CAPA), Medical Device Contract Manufacturing, Continual Improvement, Product Inspection Methods, Statistical Techniques, Measurement Systems Analysis (MSA), Non-Conforming Material Report (NMR)

Industry

Medical Equipment Manufacturing

Description

Quality Engineer II/III The Quality Engineer with have a great aptitude for learning, being 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 quality initiatives to improve and develop processes with the understanding of regulatory compliance requirements of ISO and the FDA. What you will be doing: Based in our Maple Grove, MN office, the Quality Engineer will ensure the company meets regulatory obligations as well as Deliver Customer confidence thru well performing systems. They will 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. They will also participate as a member of various cross functional teams to address Corrective and Preventive Corrective Actions and review site CAPA process. In addition, they will address quality activities in 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. What we expect from you: Our ideal candidate will have a 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 with at least 4 years of professional experience in a regulated industry. In addition, the ideal candidate will have clear understanding of the elements of ISO 13485 QMS processes and USA FDA part 820 regulations and strong interpersonal and team building skills. They will also have experience preparing for and hosting customer and regulatory audits and inspections. ASQ Certifications in Quality Engineering or Auditing, ISO 13485/9001 lead auditor and Six Sigma Black or Green Belt are a plus, but not required. What's in it for you: Competitive salary and bonus compensation. Medical, Dental, Vision, and HSA plans. Life, AD&D, STD, LTD plans to help protect you and your loved ones. Generous 401k plan with Employer Match and Profit Sharing. Paid Holidays, PTO, and other leave programs to support your time off needs. Monthly training hour allotment to continue your skill advancement. What you should know about us: We believe there is a better way to bring medical devices to market. We use an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of one's life'. Join us in our mission to be the leading provider of custom engineered solutions for top medical device manufacturers. ATL has operations in China, Costa Rica, Taiwan, UT-USA, plus remote staff in strategic global locations ... and we're growing! EEO Statement ATL Technology provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Our Mission to is partner with the world's leading medical device companies to accelerate the development and manufacturing of innovative medical devices. We look for employees who live our values; Honesty, Excellence, Accountability, Respect & Teamwork (HEART) as a part of their daily interactions with customers, peers and their communities. Introduce Yourself!

Responsibilities

The Quality Engineer will ensure regulatory obligations are met and customer confidence is delivered through well-performing systems, participating in the Quality team to improve the site Quality Management Systems (QMS) and contribute to audits. Responsibilities also include addressing quality activities in a Medical Device Contract Manufacturing environment, managing product inspection consistency using statistical techniques, and participating in the Non-Conforming Material Report process.