Software Quality Engineer

Lafayette, Colorado Software Engineering 10 days ago

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Support post-market software-related activities, including remediation and CAPA, with a strong background in requirements analysis, software documentation, and software quality assurance.

Job Requirements

  • Bachelor’s Degree in Engineering, Science, or a related technical field.

  • Minimum of 2 years of work experience.

  • Experience in the medical device industry.

  • Familiarity with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards.

  • Experience with navigation systems.

Preferred Skills

  • Expertise in requirements analysis and management, including evaluating product definition requirements and assessing test coverage.

  • Proficiency in software documentation and specification, ensuring compliance with intended use and performance criteria.

  • Strong knowledge of quality assurance and compliance, including identifying design-related gaps and implementing mitigation strategies.

Job Responsibilities

  • Support product quality to ensure medical device technologies are safe, effective, and compliant with regulations and standards.

  • Conduct evaluations of software systems activities, including requirements, design, development, documentation, integration, testing, verification, and validation.

  • Ensure projects and process control documentation align with compliance requirements and objectives.

  • Review software systems design, change specifications, and plans against process requirements.

  • Collaborate with test engineering to develop verification and validation strategies, and review and approve test protocols and reports.

Pay: 40-54

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.



Pay Details: $40.00 to $54.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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