Senior Quality Engineer - Software

Biohorizons Birmingham , AL 35202

Posted 2 months ago

The Senior Quality Engineer

  • Software can heavily influence the company's compliance with Quality System regulations and standards relating to software and associated areas such as process validation. The Senior Quality Engineer

  • Software has the authority to implement company policy at the department level. Approve software design and development documents such as those to be included in project Design History Files (DHFs) as a representative of Quality Assurance. Order and direct internal audits as they relate to Quality System elements and software. Respond to requests for information or documentation required for regulatory filings and registrations or requests from suppliers.

The responsibilities of this position include, but may not be limited to the following:

  • Develops, applies, revises, and maintains quality standards for software applications and systems that the company develops in support of manufacturing, manufacturing engineering, or quality processes

  • Develops software test and software risk management policies and leads the activities associated with the software system risk assessment

  • Participates in New Product Development (NPD) design review, design control, and related activities, regarding software systems used in manufacturing, inspection and test, process control and Quality Systems

  • Support internal/supplier audits of quality management functions, processes, and procedures with regard to software and over which the Quality Engineer has no direct control or responsibility

  • Support of other Quality Systems such as Corrective and Preventive Actions (CAPA), supplier corrective actions, and document control

  • Provide technical guidance and training to other departments and quality personnel regarding Software QA Engineering areas of expertise

  • Establishes, monitors, and complies with annual departmental budget requirements

The ideal candidate for this position will possess the following qualifications:

  • Bachelor degree required, Master's degree preferred

  • ASQ certification (e.g., Quality Manager, Engineer, Auditor) preferred

  • Two (2) years' experience in a medical device (U.S. FDA-regulated and registered) Manufacturer preferred

  • Specification Developer environment in Software Quality Engineering and/or Software Quality Assurance role required

  • Advanced computer software and internet use (Specific languages, test cases, SV&V) proficiency as well as software design and life cycle development experience/knowledge required

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Software Engineer Revenue & Quality Analytics Group

DST Systems, Inc.

Posted 1 month ago

VIEW JOBS 12/20/2018 12:00:00 AM 2019-03-20T00:00 The speed of technology. The influx of data. Shifting regulations. Increased customer expectations. That's where you'll find DST, helping clients find opportunity in ever-changing and complex customer, business, and regulatory requirements. Mastering complexity is a constantly changing and evolving challenge – one that only a few people can embrace and thrive upon. If you see your opportunity in complexity, then we are the right fit for you. Job Description: Organizational Overview DST Health Solutions provides healthcare reform through a full range of BPO and turnkey healthcare administration solutions. Our solutions, combined with our health outcomes optimization solutions, include advanced technologies and strategic consulting services designed to optimize our customer's outcomes, revenues, and managing their risk. As a leader in population health analytics for over 20+ years, DST has supported customers with risk adjustment and predictive modeling solutions by licensing the ACG System through our exclusive partnership with Johns Hopkins University. The introduction of our CareAnalyzer product in 2007 enabled us to provide health care analytics to a rapidly growing customer base. Over the last few years, DST has added additional solutions which allow customers to manage programs that directly affect their revenue: HCC risk adjustment for Medicare Advantage and Marketplace, Medicare STAR ratings, etc. Role Overview This is a key role within a small autonomous organization, and requires a high degree of flexibility. This is an opportunity to become part of a forward-thinking team, respected for the products they produce and client satisfaction which those products support. Analyzes, designs, programs, and modifies software enhancements and/or new products used in local, networked, cloud-based or Internet-related computer programs. Code may be used in commercial or end-user applications, such as materials management, financial management, mobile apps or desktop applications products. Using current programming languages and technologies, leveraging BDD (Behavior Drive Development)/TDD (Test Driven Development) methodologies, writes code, completes programming, and performs testing and debugging of applications. Completes documentation and procedures for installation and maintenance. May interact with users to define system requirements and/or necessary modifications. Adheres to Software Engineering and Information Security Controls; aligns with enterprise architectural strategies. Closes existing software defects and ensures maintenance of architectural diagrams.. Qualifications Minimal * Bachelor's degree and 3 years of work-related experience, or Master's degree and 1 year of work-related experience, or 5 years equivalent work-related experience * Proficient with C# * 4+ years of experience developing Web Applications * Experience developing Single Page Applications using Javascript frameworks such as Angular or Backbone.JS * 4+ years developing Stored Procedures using MSSQL * Experience developing web based communication services (REST APIs, Web API, WCF, WSDL, SOAP) Optimal * Experience with software quality process/assurance including automation testing, unit/integration testing, design/code review, code profiling and software CI/CD pipelines * Experience in healthcare/payer industry * Experience with package management tools such as Maven, or NuGet * Experience with distributed applications, containerization, orchestration, security and cloud architectures (SaaS, PaaS and IaaS) * Experience with multi-tiered and multi-tenant solutions * Experience with Authorization/Authentication protocols and methodologies. * Experience using Javascript visualization library Highcharts * jQuery, RHEL * Experience developinging web apps using Java Location: Birmingham Alabama DST is an equal opportunity employer and values a diverse and inclusive workplace. All qualified candidates will receive consideration for employment without regard to age, race, color, religion, genetic information, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. For more information about Equal Opportunity in the Workplace please click here and here. DST is committed to working with and providing reasonable accommodation to job applicants with disabilities. If you are a qualified individual with a disability and need an accommodation or accessibility assistance to complete the online application, please contact us at PeopleCenter@dstsystems.com for assistance. DST Systems, Inc. Birmingham AL

Senior Quality Engineer - Software

Biohorizons