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.

Whats 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.