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9 days old

Software Quality Engineer

Kelly Services
St Louis, MO 63103
Kelly Services is currently looking to hire a **Software Quality Engineer** to work for one of our top Medical Device clients on-site in **St. Louis, MO** for a direct position. This is an excellent opportunity to work for a renowned company in an exciting industry.


The **Software Quality Engineer** will assure Quality and Compliance and provide overall Quality guidance during software development and validation of embedded software in the surgical devices. In this role you will work with R&D Engineering, Project and Program Management, Regulatory Affairs, and Supplier Quality departments to design, develop, and approve software compliance efforts in embedded software.


**KEY ACTIVITIES/RESPONSIBILITIES**


+ Reviews and approves design and development planning documents and design change requests.

+ Reviews and approves product requirements, system requirements, software requirements specifications, software architecture specifications, software detailed designs requirements using requirements traceability analysis.

+ Reviews and approves Risk Management documentation.

+ Review and approve Software Integration Test, Software System Test and Design Validation Test protocols and reports.

+ Reviews and approvals ensure document deliverables with internal directives and SOPs and external industry standards and regulations.

+ Influence the requirements definition and software design to maximize quality of requirements.

+ Act as a process advisor to coordinate risk controls, specification traces, verification / validation testing, and anomalies tracking for resolution.

+ Work closely with the software development team in risk management.

+ Collaborate with other engineering disciplines, such as mechanical, electrical, and industrial design, to ensure that embedded software will accomplish design goals for a particular product.

+ Help guide R&D teams through Quality Management System to ensure software is developed in compliance to internal procedures, as well as the requirements of FDA, ISO, and other regulatory bodies.


**Requirements:**


+ Bachelors degree in computer science, Computer Engineering, or Software Engineering

+ Thorough understanding of software quality assurance principles, practices, and metrics, as well as best practices that foster high quality software.

+ Deep knowledge of embedded software testing

+ Excellent analytical, problem solving, organizational, and communication skills

+ 3 years in the field of software with hands on experience in a technical Quality role supporting a product design function in the development, testing, validation, approval, and release of embedded software in medical devices hardware.

+ Demonstrated work experience in a role within a Design Quality function with responsibility of Quality Assurance and Compliance for device software in FDA regulated products.

+ Proven record supporting the development and execution of software test protocols for complex medical devices.

+ Familiarity with EN 62304, EN ISO 14971, EN 62366, FDA regulations and international standards applicable to medical device design, development, verification, and validation.

+ Working knowledge of FDA guidance for Medical Device Software Validation


**Preferred:**


+ Former experience as a software developer using C, C++, C#, APIs, or equivalent.

+ Worked with teams on 510(k) submissions and/or PMAS


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-08-05 Expires: 2022-09-05

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Software Quality Engineer

Kelly Services
St Louis, MO 63103

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