Software Quality Engr II

Planet Pharma; Lafayette (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Planet Pharma is seeking a Quality Engineering professional to support medical device software development and commercial software products. The role requires cross-functional collaboration with R&D and Quality to implement and maintain processes and procedural controls.

The position emphasizes design quality engineering per IEC 62304, QMS processes, and cloud-based software support, with a Bachelor’s degree and roughly two years of experience.

Qualifications

• Requires Bachelor's degree and practical knowledge of software quality practices.
• Minimum 2 years of relevant experience in software quality or verification.
• Experience with cross-functional teams in R&D and Quality.

Responsibilities

• Develops, modifies, applies, and maintains standards for software 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 and compliance with project requirements.
• Ensures that project documentation aligns with contractual and process requirements and is audit-ready.
• Reviews software system design, change specifications, and plans against requirements and testability objectives.

Skills

IEC 62304

QMS processes

Cloud software

Education

Bachelor's degree

Job description

This will be a Quality Engineering role supporting both Medical Device software development and commercially available software product with the team supporting that software. This role will require cross-functional interaction with R/D and Quality to implement and provide process and procedural support.

Top 3 technical skills that are required for the role:

1.Design Quality Engineering IEC 62304

2.QMS Process and Procedure

3.Cloud Based Software Support

Education Required:Bachelors degree

Years’ Experience Required:2 years or greater

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.

Required 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