Software Quality Engineer

Pay: $55.00 - $65.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.

Top 3 technical skills that are required for the role:

1. Regulatory and compliance knowledge
2. Software verification
3. Soft skills: communication and teamwork, attention to detail, and a methodical approach to document review.

• Collaborate with cross-functional teams to evaluate product definition requirements.
• Support new product development, mainly in updating and auditing Design History Files (DHF)
• Support the remediation of design output documentation (e.g. software architecture documentation, software form and behavior specification) by ensuring they meet the intended use and performance criteria specified in the product requirements.
• Identify potential design-related gaps due to remediation efforts and ensure that appropriate mitigation strategies are in place.
• Assess test coverage is complete with regards to requirements and design outputs traced (including identifying gaps and unnecessary traces).
• Document and report remediation results, providing clear insights and recommendations for future improvement.
• Follow all Quality System Practices as defined by *** Navigation's practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
• 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.

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

Years' Experience Required: 4+years

• Medical device design, development & manufacturing, experience of products with electrical functionality an advantage
• Examples of critical thinking and proven project execution
• Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc.
• Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution.
• Lead team to define goals, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team.
• Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
• Use scientific problem solving methodologies e.g. DMAIC, process map, 5 whys, Is/Is not, etc. Drive solid decision making.
• Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance).
• Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges.

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