Quality Engineer I #26-17850 US Tech Solutions, Inc.
St. Paul, MN8 days ago
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Skills
- Analysis Skillsunmatched
- Assembly Lineunmatched
- Change Controlunmatched
- Code Reviewsunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Computer Softwareunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Digital Rights Management (DRM)unmatched
- Documentationunmatched
- Equipment Validationunmatched
- Experiment Designunmatched
- Failure Mode and Effects Analysis (FMEA)unmatched
- ISO (International Organization for Standardization)unmatched
- Industry Standardsunmatched
- Integration Testingunmatched
- Manufacturingunmatched
- Medical Equipmentunmatched
- Organizational Skillsunmatched
- Procedure Implementationunmatched
- Process Validationunmatched
- Product Supportunmatched
- Project/Program Managementunmatched
- Quality Engineeringunmatched
- Quality Managementunmatched
- Quality Metricsunmatched
- Quality System Requirements (QSR)unmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Risk Analysisunmatched
- Root Cause Analysisunmatched
- Software Administrationunmatched
- Software Designunmatched
- Software Engineeringunmatched
- Software Evaluationunmatched
- Software Validationunmatched
- Statisticsunmatched
- System Validationunmatched
- Technical Presentationunmatched
- Technical Writingunmatched
- Testabilityunmatched
- Testingunmatched
- Traceabilityunmatched
- United States Department of Energy (DOE)unmatched
- Validation Testingunmatched
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.
Numbers & Facts
| Location | Brooklyn Center, MN |
| Industry | Staffing/Employment Agencies |
| Salary | $50 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
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