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Software Quality Engr II

Lafayette, CO 80026

Posted: 01/13/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 616806 Is job remote?: No Country: United States

Job Description


Pay 65-72/h depending on experience

\Top 3 technical  skills that are required for the role:
  1. Requirements Analysis and Management: This skill is crucial for evaluating product definition requirements, ensuring that software product requirements are clear, complete, and testable, and assessing test coverage with respect to requirements and design outputs.
  2. Software Documentation and Specification: The ability to review and remediate design output documentation, such as software architecture documentation and software form and behavior specifications, is key. This includes ensuring these documents meet intended use and performance criteria.
  3. Quality Assurance and Compliance: Knowledge and experience in quality assurance practices, especially related to following Quality System Practices and meeting FDA, ISO, and European Medical Device standards and regulations, are essential. This includes identifying design-related gaps and implementing mitigation strategies.

Education Required: Bachelor’s Degree in Engineering, Science or technical field

Years’ Experience Required: Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.


This position has the opportunities to work with corss-functional team members to support Post Market Software related activities:
  • Post Market Release lifecycle, such as remediation, CAPA, and other activities as assigned.

Responsibilities may include but not limited to the following activities, with mentor/coach/guidance from more senior Software quality engineers:
  • Supports product quality ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices. 
  • Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
  • Reviews software systems design, change specifications, and plans against process requirements.
  • Collaborate with test engineering on verification and validation strategies, review and approve test protocols and reports.

EDUCATION REQUIRED: 
  • Bachelor’s Degree in 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

Nice to Have
  • Experience in the medical device industry
  • Experience with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards
  • Navigation systems experience preferred
  • Excellent oral and written communication skills

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Lafayette, CO

Ready to take your career to new heights? Explore job opportunities in the vibrant area surrounding Lafayette, Colorado! Located in Boulder County just a stone's throw away from Denver, Lafayette boasts a perfect blend of small-town charm and big city amenities. With a thriving arts scene, including galleries like The Collective Community Arts Center and performances at the Mary Miller Theater, as well as easy access to outdoor adventures at Waneka Lake Park and Indian Peaks Wilderness, this area offers a unique mix of culture and natural beauty. Join our team and discover why Lafayette, CO is the perfect place to grow both personally and professionally. Start your job search today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.