IT Quality Engineer at BAUSCH HEALTH in St Louis, MO: Direct Hire + Bonus to Mov

Kelly Services, Inc. is happy to exclusively present a DIRECT HIRE opportunity for a role as an IT Quality Engineer at BAUSCH HEALTH in St Louis, MO

***BONUS on HIRE to move to affordable St Louis! ***

3 Reasons why you should apply

  • You have excellent familiarity with the development of apps and cloud (SaaS, IaaS, PaaS)!
  • You are a collaborator with a thorough understanding of software quality assurance principles, practices and metrics, preferably in a FDA regulated environment.
  • You have 3+ years in the field of cloud computing technology and services, with at least 1 years of hands on experience in a technical Quality role

The Details:

  • This DIRECT HIRE role is in St Louis, Missouri onsite at Bausch Health
  • Monday-Friday 8:00 PM-5:00 PM!!
  • $65,000 – $96,000 /year. Negotiable based on experience! LET’S Talk!
  • Again: ***BONUS on HIRE to move to affordable St Louis! ***
  • Apply Now for Interview!

JOB OVERVIEW:

The IT Quality Engineer at BAUSCH HEALTH is responsible to assure Quality and Compliance and provide overall Quality guidance during development and validation of apps, virtual servers (clouds), management of device-generated data, and cyber security.

 

  • The roles and responsibilities for this position are combined as a Design Quality Engineer with emphasis in modern Information Technologies.
  • Scope of the referenced key activities and responsibilities is primarily project-based, with extended scope for the development and/or update of procedures, work instructions, forms and templates required to execute this role.

Day to Day Job Activity:

  • Reviews and approves design and development planning documents and design change requests.
  • Reviews and approves product requirements, system requirements, apps requirements specifications, cloud infrastructure, platform and application.
  • Reviews and approves Risk Management documentation.
  • Review and approve Apps Test, cloud 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 to ensure the appropriate scope of the device is clear with its interface with the clouds using apps, and any non-medical electronic device is separated from the device accessories.
  • Act as a process advisor to coordinate risk controls specification traces, verification / validation testing, and anomalies tracking for resolution.
  • Work closely with the apps and clouds development team in risk management.
  • Collaborate with other engineering disciplines, to ensure the apps, the clouds and the interface with the medical device will accomplish design goals for a particular product.
  • Help guide R&D teams through Quality Management System to ensure apps, clouds, interfaces and cyber security are developed in compliance to internal procedures, requirements from FDA, ISO, and other regulatory bodies.

Candidate Qualifications and Skills for Success:

  • Required Education: Bachelor Degree in Computer Science, Computer Engineering, or Software Engineering.
  • 3+ years in the field of cloud computing technology and services, with at least 1 years of 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 and its interfaces with apps and data storage in virtual servers (clouds).
  • Thorough understanding of software quality assurance principles, practices and metrics, as well as best practices that foster high quality software, apps and clouds.
  • Deep knowledge of the use of apps for medical devices and its interface with cloud platforms.
  • Excellent analytical, problem solving, organizational, and communication skills.
  • 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. Hands-On experience with network\storage devices\solutions.
  • Work experience with data management, apps, cyber security, cloud computing, and interfaces with medical device equipment.
  • 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 Experience.
  • Former experience as a software developer using C, C++, C#, APIs, or equivalent.
  • Former experience supporting development and validation of private or public clouds.
  • Worked with teams on 510(k) submissions and/or PMAS.
  • Familiarity with the development of apps and clouds (SaaS, IaaS, PaaS)

Additional Detail:

  • Due to the high volume of responses anticipated, only qualified candidates can be contacted.
  • We appreciate all our applicants, but we are not able to sponsor now; no C2C or H-1B.
  • There is no ‘per diem’ with this position, and must be able to work on W-2 hourly basis.

This role is supported by the Kelly Services GTS – Recruiting and Sourcing division. 

As your local offices do not support this position, for immediate consideration please APPLY ONLINE to this posting directly, or on the Kelly Career Network https://kelly.secure.force.com/CandidateExperience/

Why Kelly®?

With Kelly, you’ll have direct connections to leading IT organizations in the best companies around the globe—offering you the chance to work on some of today’s most intriguing, innovative and high-visibility projects. In a field where change is the only constant, our connections and opportunities will help you take your career exactly where you want to go. We work with 90 of the Fortune 100™ companies companies and found opportunities for more than 8,600 IT professionals last year. Let us help advance your career today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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. 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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