Sr Software Quality Engr - Exempt

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. 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.

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

Nice to Have

• DRM Greenbelt Certification

Responsibilities

• 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.

Top 3 Candidate Experience Requirements

• 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.

Required Knowledge and Experience
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.