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Software Quality Engr II - Exempt

Lancesoft

  • Lafayette, CO
  • 16 days ago
  • $40

Highlights

Understanding of medical device regulations, including EU MDR, ISO 13485, and IEC 62304, and the ability to keep devices compliant with evolving regulations. We are seeking a Software Quality Engineer to support both Medical Device software development and commercially available software products.

Numbers & Facts

LocationLafayette, CO
IndustryStaffing/Employment Agencies
Salary$40
Company Size2,000 to 2,499 employees
Year Founded2000
Websitehttp://www.lancesoft.com/

Description


Join our dynamic team in Lafayette, CO, where innovation meets quality. We are seeking a Software Quality Engineer to support both Medical Device software development and commercially available software products. This hybrid role offers the opportunity to work onsite four days a week, collaborating with cross-functional teams to ensure the highest standards of software quality and compliance.
Must Have:
  • Expertise in computer and software validation and change control of Medical Devices.
  • Understanding of medical device regulations, including EU MDR, ISO 13485, and IEC 62304, and the ability to keep devices compliant with evolving regulations.
  • Experience with non-medical product development processes and lifecycle requirements.
  • Ability to serve as the voice of the Software Systems function, providing guidance from a software and systems perspective.
  • Expertise in training development and delivery.
  • Broad understanding of medical device development, regulation, and approval in the EU and US.
  • Familiarity with emerging AI-related standards and requirements.
  • Expert-level process development skills for creating quality system documents for diverse users and product types.
  • Advanced understanding of design controls, quality system regulations, and failure investigation methodologies.
  • Ability to apply design control principles and quality engineering techniques throughout the product development process.
  • Proficiency in defect analysis and the design and implementation of quality testing and validation tools.
  • Experience in developing and implementing processes and procedures.
Nice to Have:
  • 0-3 years of medical/clinical experience or exposure.
  • 2 years of Medical Device experience.
  • Experience with Agile QMS and Cloud Based Software.
  • Knowledge of NC/CAPA.
Responsibilities:
Responsibilities may include the following and other duties may be assigned:
  • Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
  • Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
  • Define appropriate measures to ensure product quality.
  • Develop overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
  • Ensure that projects and process control documentation are compliant with requirements and objectives.
  • Review software systems design, change specifications, and plans against contractual and/or process requirements.
  • Provide or direct verification and validation of software system requirements, traceability, and testability.
Education and Experience:
  • Bachelor's degree required.
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Be a part of our team and contribute to the development of cutting-edge medical device software in a collaborative and innovative environment in Lafayette, CO.

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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