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Software Quality Engr II - Exempt

Lancesoft

  • Brooklyn Center, MN
  • 30+ days ago
  • $40
  • Instant Apply
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Skills

  • Analysis Skillsunmatched
  • Assembly Lineunmatched
  • Code Reviewsunmatched
  • Code of Federal Regulationsunmatched
  • Contract Processingunmatched
  • Contract Requirementsunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cost Analysisunmatched
  • Digital Rights Management (DRM)unmatched
  • Document Managementunmatched
  • Documentationunmatched
  • Equipment Validationunmatched
  • Experiment Designunmatched
  • Failure Mode and Effects Analysis (FMEA)unmatched
  • ISO (International Organization for Standardization)unmatched
  • Industry Standardsunmatched
  • Integration Testingunmatched
  • Interpersonal Skillsunmatched
  • Inventory Managementunmatched
  • Manufacturingunmatched
  • Medical Equipmentunmatched
  • Medical Office Administrationunmatched
  • Operations Processesunmatched
  • Presentation/Verbal Skillsunmatched
  • Procedure Implementationunmatched
  • Process Control Engineeringunmatched
  • Process Qualityunmatched
  • Process Validationunmatched
  • Product Supportunmatched
  • Product Testingunmatched
  • Production Controlunmatched
  • Project Controlunmatched
  • Quality Assuranceunmatched
  • Quality Assurance Methodologyunmatched
  • Quality Engineeringunmatched
  • Quality Managementunmatched
  • Quality Metricsunmatched
  • Quality System Requirements (QSR)unmatched
  • Regulationsunmatched
  • Regulatory Requirementsunmatched
  • Research & Development (R&D)unmatched
  • Risk Analysisunmatched
  • Root Cause Analysisunmatched
  • Software Administrationunmatched
  • Software Designunmatched
  • Software Engineeringunmatched
  • Software Evaluationunmatched
  • Software Validationunmatched
  • Statisticsunmatched
  • System Validationunmatched
  • Systems Maintenanceunmatched
  • Technical Presentationunmatched
  • Test Plan/Scheduleunmatched
  • Testabilityunmatched
  • Testingunmatched
  • Traceabilityunmatched
  • United States Department of Energy (DOE)unmatched
  • Validation Testingunmatched
  • Writing Skillsunmatched

Description


Join our team at the *** Energy and Component Center (MECC) located in the vibrant Brooklyn Center, MN. In this exciting role, you will have the opportunity to provide comprehensive manufacturing quality support for commercial medical devices within component manufacturing. This includes activities related to development, test method validation, process validation, inspection improvements, and process/quality change initiatives.
Responsibilities
  • Provide Software Quality Engineering support for new product commercial medical device component manufacturing lines.
  • Develop, modify, apply, and maintain quality standards and protocols for processing materials.
  • Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • 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.
  • Design or specify inspection and testing mechanisms and equipment;conduct quality assurance tests;and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
  • 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 including Risk analysis FMEA, statistical techniques such as six-sigma and DOE (design of experiments), root cause analysis, and reading and correcting drawings.
Additional Responsibilities
  • Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
  • Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
  • Defines appropriate measures to ensure product quality.
  • Develops overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
  • Ensures that projects and process control documentation are compliant with requirements, objectives, and/or contracts.
  • Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
  • Reviews include applicable specifications, materials, tools, techniques, and methodologies.
  • Provides or directs verification and validation of software system requirements, traceability, and testability.
Qualifications
  • Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience.
  • Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
  • 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.
  • Excellent verbal and written communication, analytical, influencing, and interpersonal skills.
Preferred Qualifications
  • DRM Greenbelt Certification

This position offers a full-time schedule of 40 hours per week, with the requirement to be on-site at the MECC Facility 4 days per week.

Numbers & Facts

LocationBrooklyn Center, MN
IndustryStaffing/Employment Agencies
Salary$40
Company Size2,000 to 2,499 employees
Year Founded2000
Websitehttp://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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