Quality Manager


Manufacturing and Production

Advert ID



New Prague

Job Type




Salary Range

USD100000.00-140000 per year

No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description

Our team is requiting a talented Leader focused on Quality with a strong LEAN background to join our New Prague, MN team. Responsible for providing leadership, employee development and focus to your team, you will be involved in all aspects of Electromed quality, from maintenance of the documented ISO 13485 quality system and participating in FDA and ISO audits to ensuring product quality meets expectations. As we are currently implementing the Grand Avenue Quality System software as our new quality system platform and are just finishing up the document control and training modules you will lead implementation of future modules including CAPA, equipment, non-conforming material, complaints, internal audit, and design control. If you're excited to be part of a winning team, Electromed is a great place to grow your career. You'll be glad you applied to Electromed, Inc.

Job Outcomes You Must Get:

* Collaborate with the upper management team to set quality benchmarks.

* Provide leadership for Electromed's ISO 13485 Quality System and ensure ongoing successful audits.

* Document requirements in accordance with industry standards and customer expectations.

* Identify quality control processes to ensure criteria are always met.

* Manage and mentor the Quality Inspector and Quality Engineer.

* Monitor tests to check final product adherence to the company standards.

* Record findings and relay information to the production team.

* Brainstorm ideas to increase productivity and performance of the production line while maintaining accuracy in quality.

* Make crucial decisions in favor of cost-efficiency without compromising on quality.

* Prioritize tasks to keep production running when issues arise.

* Participate in Industry and FDA audits.

* Contributing member of the new product design team.

Job Outcomes Requirements:

* Significant experience in an FDA regulated industry.

* Experience as a quality manager in a medical device manufacturing environment.

* Familiar with company and industry quality standards and processes both domestic and foreign including ISO 14971, ISO 13485, EU MDD and EU MDR.

* LEAN certified

* Proficient in computer technology, systems, and Microsoft Office applications.

* In-depth knowledge of market trends and conditions.

* Exceptional analytical and problem-solving abilities.

* Team player and strong leader with excellent management and interpersonal skills.