Eqms Champion/Qms Engineer (Aka Qms Specialist Medical Devices Or Systems)
Believe Resourcing (Pty) Ltd
Johannesburg, Gauteng
6d ago
source : findojobs-za

Client Introduction : We are a well-funded start-up, and in everything we do, we focus on empowering people to monitor and make informed health decisions proactively.

We are simply bridging the gap in healthcare by taking privilege out of it using our patented solutions that allow you to manage your degrees of care easily.

We bring together the brightest minds to create disruptive technology solutions, helping our customers live healthier lives.

  • As our vision, we believe we are on the face of a digital world making access to healthcare and wellbeing accessible to all by making great user-centric products;
  • we are not about to change.Our mission is to provide healthcare equity by being the backbone of good health and wellness through innovative technologies for a new human-centric economy where the user controls their health because personal health and wellbeing have become the new currency.

    This is a unique opportunity to join our growing team, build new products, and scale our systems to meet a >

    20x surge in demand during the next 12-18 months. We are truly a full-stack company, mobile, and cloud-first, with a great set of technical challenges to work on.

    Client valuesUser first, the rest will fall in place : "great " just doesn't cut it for usAccessibility & simplicity : geological position should not restrict access care & informationCompassion : communicating with impactCIA triangle badge : we ensure system confidentiality, integrity, and availability.

    Innovation : change is inevitable; we embrace it through agilityDeveloping self & others drive result"The Collaboration Dance " is our signature moveWhat do they do?

    Our product is a smart 'anywhere' health monitoring system that allows users to create and manage a degree of their health data, allowing them to proactively monitor and make informed health decisions.

    Other healthcare tools are costly, complex, and intimidating, whilst ours is beautiful and simple, and our customers love it.

    Why you should join them : "We have promised to foster true innovation and create something enduring that can influence society by affording dignity to each person, regardless of social standing or background.

    We define our digital voice as passionate, requiring self-expression, daring, Inspirational, challenging the status quo. Highly dedicated and achievement-oriented with a highly developed aestheticWe are motivated by the idea of creating something new, unique, exciting, and innovative that will have meaning and endure valueWe fear conforming, stagnation, familiarity, disenchantment, and mediocrityOur goal is to help customers express or create and foster the best version of themself with dignity while using creative thinking to solve their problemsOur motto is "creativity take a challenge, do not copy, create"We're on a mission to drive digital healthcare and wellbeing inclusion across Africa and disrupt traditional health monitoring and screening, and, in the process, define a new currency in health data.

    We have successfully built and tested our disruptive technologies. We are at a point where we can extend this to South Africa and Africa as a wholeCurrently, we operate from Johannesburg, with plans to scale across Africa, serving 1 million people by the end of .

    We are a well-funded start-up which now gives us a significant runway to scale our team and deploy our capabilities sooner.

    You'll have the opportunity to use your expertise to shape the future of our products and drive our strategy to impact our success directly.

    What we're doing has never been done before. You'll have the opportunity to use your expertise to shape the future of our product and drive our strategy to impact our success directly.

    About youIf you have exposure and experience with software testing and also familiar with medical devices or the pharmaceutical industry.

    We are looking for a Quality Systems Specialist. In this role you will act as the administrator and SME as it relates to the configuration, implementation, analysis as well as maintenance of our electronic quality management system (eQMS).

    You will provide quality oversight and also be responsible for managing the late Items program, monitoring the due dates for all types of investigations, change controls and other controlled documents, ensuring items are closed within the approved timelines.

    If you have...Working knowledge of #FDA (#21CFR , # & #) and #EU regulatory requirements - a bonusPrevious experience implementing or administration of an #eQMS software system - a mustExperience and exposure with quality standards related to medical device software ie #ISO & #ISO & #ISO (QMS) - a must! Experience with #IEC - a bonusMust have a #Diploma / BA / BS in life sciences, #information technology, or relevant field with #5+ years of relevant experience, preferably in the health or medical regulated environment#Six Sigma certified - a must or have related experience to prove sameServe as #QA subject matter #expert (SME) for #eQMS.

    Act as #committee chair or member for all #software steering committees which have an impact on the quality system. This includes participating in all teams to modify or upgrade the system.

    Responsible for #maintaining the eQMS system and #performing tasks related to continuous improvement of this #electronic QMS system.

    Develop or #review protocol, #plans, #scripts, #reports, #SOPs etc. associated with the #implementation and #maintenance of #computerized systemsServe as the #QA contributor on projects including inquiries pertaining to the interpretation of regulatory requirements for computer #system validation#Execute document and change control processes to ensure #standardization, #accuracy, and #completeness of documents prior to release.

    Assist in the execution and / or review of computer system #validation documentation.Assist in #training other departments in the use of #electronic documentation systems.

    This includes providing one-on-one training as well as group training.#Review and #evaluate reports from the documentation and change control systems and other information as deemed necessary.

  • Investigate trends, #prepare reports and #notify management of issues needing further review.Assist in preparation for #Quality Affairs Committee and attend #QAC meetings;
  • take minutes and #prepare meeting minutes.Continuously evaluate areas of responsibility and recommend improvements to the processes concentrating on efficiency and quality of the product and / or systems.

    Ensure #Key Performance Indicators measure progress against #Quality objectives.#Support and #facilitate change control processes.

    This includes a partnership with change control owners to assist them in the development and execution of change controls or completion of tasks.

    Have experience in software testing and even be #ISTQB certified ie experience with software testing and Quality AssuranceWorking knowledge of #Windows office systemsHave an awareness of #Agile / Scrum methodologies or have worked in an Agile / Scrum team.

    Technical experience with the #Mobile and #Web Application DevelopmentAtlassian tool suite ( #Jira, #Confluence)The recruitment processOur hiring process shouldnt be based on human judgement alone.

    Infused assessments to run fair and objective test campaigns.Reveal potential candidates abilities without bias so that our tech team is filled with diversity, boost creativity and cultivate innovation.

    Shortlisted candidates : 1) Undergo a screening technical test (evaluate candidates coding skills with tech-friendly, hands-on programming tests)2) A technical live test (developers to write, execute and debug code as part of our technical interview process)3) In-person interview & offer if successful4) 3-months-notice then permanent

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