ATL Technology · 12 hours ago
Quality Engineer II/III
Maple Grove, MN
Full-time
Onsite
Mid, Senior Level
4+ years expATL Technology is focused on bringing medical devices to market with an engineer-to-engineer approach. The Quality Engineer will support the growth of the quality department by ensuring regulatory compliance and enhancing quality management systems while collaborating with cross-functional teams.
ElectronicsManufacturing
Responsibilities
Ensure the company meets regulatory obligations as well as deliver customer confidence through 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 and review site CAPA process
Address quality activities in Medical Device Contract Manufacturing environment and 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
Qualification
Required
Bachelors in a technical / scientific discipline such as Manufacturing, Mechanical Engineering, Electrical Engineering, Physics, or similar technical degree
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
Clear understanding of USA FDA part 820 regulations
Strong interpersonal and team building skills
Experience preparing for and hosting customer and regulatory audits and inspections
Preferred
ASQ Certifications in Quality Engineering or Auditing
ISO 13485/9001 lead auditor
Six Sigma Black or Green Belt
Benefits
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.
Company
ATL Technology
ATL Technology is an electronic manufacturing company offering electromechanical manufacturing services.
1001-5000 employees
H1B Sponsorship
ATL Technology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2020-01-01Private Equity
Leadership Team
David Smith
Chief Operating Officer
Recent News
Google Patent
2025-05-05
Medical Product Outsourcing
2025-03-21
2025-02-22
Company data provided by crunchbase