SOFTWARE QUALITY ENGINEER CFR part 11

SOFTWARE QUALITY ENGINEER CFR part 11

24 Dec 2024
California, Unioncity, 94587 Unioncity USA

SOFTWARE QUALITY ENGINEER CFR part 11

Vacancy expired!

Minimum Required Skills:
Software Quality Engineer, CFR part 11, ISO13485, C/C, Python, Lean Sigma, Medical Device, diagnostic device software, Six Sigma

If you are a SOFTWARE QUALITY ENGINEER CFR part 11 with experience, please read on! The Software Quality Engineer will be the system owner for software quality function and play an integral role in design activities for the site. This position reports directly to the Quality Operations Lead and will serve as the site Software Quality Engineer. The incumbent will plan, organize, and report on all software quality-related activities to assure fulfillment of CFR part 11 and 820, and ISO13485 requirements.

What You Will Be Doing

The Software Quality Engineer will develop, modify, and execute software test plans, automated scripts and programs for testing. Maintains documentation of test results to assist in debugging and modification of software. Analyzes test results to ensure existing functionality and recommends corrective action. Consults with development engineers in resolution of problems. Provides feedback in preparation of technical appraisals of programming languages, systems, and computation software. Ensures quality computer integration into the overall functions of scientific computation, data acquisition, and processing.
Directs the activities of a software quality assurance function.





Support Product Development:

o Participate in software product development meetings, such as Design Reviews and Risk Management

o Develop software verification and validation protocols for analyzer products; e.g., chemistry algorithms, user interface, external communication

o Execute the approved software V&V protocols.

o Generate software V&V reports.

o Track software defects and change requests in support of software configuration management.

o Review and approve Software Design History File (DHF) documents and ensure compliance to Design Control requirements.



Support Manufacturing and the Quality System:

o Develop software V&V protocols, execute protocols, and generate reports for various databases, automation equipment software, test systems, and custom software.

o Utilize databases to analyze data and generate reports in support of Manufacturing, Development, and Quality Assurance.

o Perform software development audits of OEM suppliers

o Ensure effective development, implementation and support for electronic quality system in accordance with 21 CFR Part 11.

o Facilitate assigned complaint, CAPA and NCMR investigations to root cause and ensure timely and effective closure.

o Track, review and approve Software Change Requests.

o Work with IT to get the SQL queries written such that desired reports can be generated and validated.

o Interpret and report testing results, and be a vocal proponent for quality in every phase of the development process

What You Need for this Position

Undergraduate degree in Computer Science or related field. Relevant advanced degree preferred
" 10+ years of experience in software development and testing processes of commercial software; strong preference for medical device or diagnostic device software experience.

" Must understand the Software Product Development Cycle and the crucial role of V&V and quality assurance in that cycle.

" Demonstrated ability to work with the software design engineers from product concept through product introduction.

" Working knowledge of 21 CFR Part 11, 21 CFR Par 820, ISO 13485 and ISO 14971 key principles.

" Experience with software development for embedded systems with a working knowledge of C/C and/or Python a strong plus

" Capable of development of software quality assurance and software verification & validation tools utilizing Microsoft Excel, Access, and SQL databases.

" Efficient strategies for unit, integration, and system level software verification & validation activities

" Configuration management and change control of code and documentation

" Demonstrated experience with Software Design Control and Risk Management.

" Experience in Using and maintaining a Bug Tracking System



TECHNICAL SKILLS and COMPETENCIES REQUIRED

Indicate the technical skills required and/or preferred, as applicable.

Include skills and knowledge essential to perform the position.



" Fluency in quality systems and regulatory compliance.

" Ability to develop and build a strong leadership team which can support the business

" Exercises Good Judgment and Drives Change

" Strong written and oral communication skills

" Inspires Continuous Improvement and Breakthrough Thinking utilizing problem solving tools such as Lean and Six Sigma

" Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives

" Proficient in English

" Demonstrated written communication skills, as well as experience with presenting to leadership teams.

" Business Awareness & ContinuitySo, if you are a SOFTWARE QUALITY ENGINEER CFR part 11 with experience, please apply today!

Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume!

Looking forward to receiving your resume and going over the position in more detail with you.

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Looking forward to receiving your resume!

CyberCoders


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