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Sr Software Quality Engr - Exempt
Posted: 07/06/2026
Industry: Pharma/ Med Device Engineering
Job Number: 26-92576
Pay Rate: 50-55 USD/Hour
Job Description
Join our team in Brooklyn Center, MN, a vibrant location offering a unique blend of urban and suburban living. As a Senior Software Quality Engineer, you will play a pivotal role in ensuring the quality of our commercial medical devices within component manufacturing.
Must Have
- Computer and software validation
- Change control of Medical Devices
- Investigation and root cause analysis skills
- Technical writing knowledge
- Organization and Communication skills
- Process Validation and Computer software validation knowledge
- DRM Greenbelt Certification
- Develop, modify, apply, and maintain quality standards for software systems.
- Conduct evaluations of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
- Define appropriate measures to ensure product quality and compliance with requirements, objectives, and contracts.
- Review software systems design, change specifications, and plans against requirements.
- Provide or direct verification and validation of software system requirements, traceability, and testability.
- Provide Software Quality Engineering support for new product commercial medical device component manufacturing lines.
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
- Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
- Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.
- Present technical data to groups within the organization.
- Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root cause analysis, reading and correcting drawings.
- Experience with Software Validation for equipment used in production.
- Experience using SPC, CAPA, NCMR, PDP processes.
- Working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485: 2016.
Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Work Details
Education Required: Bachelor’s Degree in Software Engineering, Science, or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science, or technical field with 2 years of work experience in Engineering and/or Quality.
Work Schedule: 40 hours a week, on-site 4 days per week.
Work Location: Brooklyn Center, MN, local to the MECC Facility.
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Login to save this search and get notified of similar positions.About Brooklyn Center, MN
Explore exciting job opportunities in and around Brooklyn Center, Minnesota! Nestled in Hennepin County, this vibrant area offers a perfect blend of urban conveniences and natural beauty. With easy access to the nearby Mississippi River and picturesque parks like North Mississippi Park, there are plenty of opportunities for outdoor adventures. The region boasts a rich cultural scene, from catching a show at the Historic Avalon Theater to exploring local art galleries like the Traffic Zone Center for Visual Art. Don't miss out on savoring the diverse cuisine options, from classic Midwestern dishes to trendy fusion eateries. Consider building your career in this dynamic area and discover the unique charm and growth potential Brooklyn Center has to offer.
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CEO, LanceSoft
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