Software Quality Assurance Engineer

Software Quality Engineer9 month contract Hybrid in Denver, CO (4 days onsite weekly)Large client in medical devices industryJob description: This will be a Quality Engineering role supporting both Medical and Non Medical Device software development and commercially available software product with the clinical team supporting that software. This role will require cross-functional interaction with clinical support, R/D, and Quality to implement and provide process and procedural support. This role will also aid in software defect resolution and provide support for NC/CAPA. Responsibilities may include the following and other duties may be assigned.

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. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy:

Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence:

Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Requirements: TECHNICAL SKILLSMust Have1. Investigation and root cause analysis skills, 2. Technical writing knowledge, 3. Organization and Communication skills, 4. Process Validation and Computer software validation knowledge• Apply knowledge of design control principles and quality engineering techniques throughout the product development process.

Can provide instruction and guidance of processes and proceduresdefect analysis skillsdevelopment and implementation of processes and proceduresNice To Have0-3 years of medical/clinical experience or exposure2 years Medical Device experienceAgile QMSExperience in Cloud Based SoftwareNC/CAPATop 3 technical skills that are required for the role: 1. Quality Engineering 2. QMS Process and Procedure 3. Software Issue Resolution Education Required: Bachelors degree Years’ Experience Required: 2 years or greaterRequired Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.

Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.