Compliance Quality Engineer, Qualitest
Salary not provided
Mid and Senior level
Remote from Canada, US
Software testing and quality assurance
Job no longer available
Software testing and quality assurance
1001+ employees
B2BArtificial IntelligenceEnterpriseBig dataDeep TechAnalyticsConsultingSaaSBlockchainDevOpsAutomationCloud Computing
Job no longer available
Salary not provided
Mid and Senior level
Remote from Canada, US
1001+ employees
B2BArtificial IntelligenceEnterpriseBig dataDeep TechAnalyticsConsultingSaaSBlockchainDevOpsAutomationCloud Computing
Company mission
To provide the best software testing teams in the world.
Role
Who you are
- Bachelor's degree in Computer Science, Information Technology, Biotechnology, or a related field or equivalent experience
- Professional certifications such as Certified Quality Engineer (CQE), Certified Information Systems Security Professional (CISSP), ITIL certifications, or similar qualifications are strongly desired
- Proven experience (3+ years) in quality engineering, compliance, and ITSM roles within the biotech, pharmaceutical, or healthcare industries
- Solid understanding of FDA regulations (including 21 CFR Part 11), ISO 13485/14971, security standards (ISO 27001), IEC 62304, and other relevant compliance frameworks as applicable to the development, validation, deployment and maintenance of product software used in the quality system to support software systems such as: medical devices, lab, support, and research use/investigational use
- Experience with a comprehensive SDLC driven agile software development environment using applicable tools
- Strong knowledge of ITSM principles and best practices, with hands-on experience in implementing ITSM processes
- Excellent project management skills, with the ability to manage multiple tasks and initiatives simultaneously
- Exceptional attention to detail, analytical thinking, and problem-solving abilities
- Effective communication skills, including the ability to convey complex compliance and ITSM concepts to non-technical stakeholders
- Collaborative and team-oriented approach, with the ability to work seamlessly across cross-functional teams
- Experience in conducting compliance audits, risk assessments, and incident management
- Proficiency in relevant tools and software used in compliance management and ITSM such as Jira, SharePoint, MS Office suite, Reliance, Confluence
- Experience with Agile methodologies such as Lean, Kanban, Scrum
What the job involves
- We are seeking a highly skilled Software Quality Engineer to join our Compliance Team in a fast-paced and innovative biotech company
- The successful candidate will work closely with software engineering teams, senior SQE’s, IT teams, and cross-functional stakeholders to implement and maintain compliance practices while providing oversight to software development activities (product development and continuous improvement) and assisting with the implementation of IT Service Management (ITSM) best practices
- Provide support to Compliance, Software Engineering, and IT teams during compliance audits and assessments
- Stay up to date with evolving regulatory requirements, industry best practices, and technological advancements to proactively address potential compliance challenges
- Provide guidance and support in resolving software and IT compliance-related incidents and issues, fostering a culture of continuous improvement
- Conduct regular audits and assessments to ensure ongoing compliance with FDA regulations, security standards, and other relevant requirements
- Provide oversight to software inventory activities, ensuring pre-requisites including vendor assessments, security assessments and other actions are completed
- Collaborate with software engineering teams to ensure that software development and deployment processes are compliant with FDA regulations and other applicable industry standards and guidelines
- Lead efforts to identify software compliance gaps, potential risks, and areas for improvement within software engineering processes
- Review software system and software release-level artifacts for product software to ensure their accuracy, clarity, consistency, completeness, and compliance to applicable standards and guidelines including software specifications/requirements documents, verification and validation protocols and reports, and risk management documents
- Contribute to production bug review for patient safety, infosec, and privacy concerns and research identified issues root cause analyses, mitigations, and resolutions
- Oversee initial software risk assessment to determine the appropriate level of validation and coverage under the SDLC process or a separate business system software validation process
- Ensure that product software and business system software are properly validated per the determination made during software inventory activities
- Participate in risk assessments, root cause analyses, and corrective/preventive action planning related to software compliance and ITSM issues
- Work closely with IT teams to design and implement effective ITSM practices, including incident management, change management, problem management, and configuration management
- Oversee and manage the company's existing IT processes and workflows, ensuring they align with ITSM principles and industry best practices. Develop and maintain comprehensive documentation of IT compliance procedures, IT processes, and ITSM workflows
Our take
The digital revolution is in full swing, and companies are rapidly looking to transform their operations; but doing so affordably, quickly, and while keeping risk as low as possible, can present a challenge. Qualitest supports digital transformation by providing quality assurance, quality engineering and digital engineering services for businesses; ensuring the success of their technologies and helping them to achieve business assurance.
Qualitest, founded in 1997, today offers a wide range of AI-powered quality assurance solutions, designed to reduce the risks associated with digital adoption. For example, its AI-powered tool Qualisense improves risk-based testing strategies – which speeds up time to-to-release and can help to cut costs – by finding failures more quickly and effectively than other methods. With such a wide range of solutions, the company is able to tailor delivery for tech platforms across a multitude of industries, from telecom to media to utilities.
Qualitest is a global company with operations across several countries, and is working to enhance its global delivery capabilities. It has grown substantially, partially by a series of strategic acquisitions, and continues to partner with other technologies to further improve the functionality of its offerings.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
4% employee growth in 12 months
Company
Company benefits
- Loyalty Program, Equity: Top performers are able to be a part of Qualitest’s Shadow Equity scheme – our success is your success.
- External Leadership Programs: We offer employees the support, tools and knowledge to become leaders and progress their career and personal development.
- Elevate Your Experience: At Qualitest, you’ll have the chance to support the best-known, most influential global brands, strategizing solutions in an incredible range of technologies, across time zones and all major industries.
- Deepen Your Skills: The chance to create change is one of our key drivers. Our expertise in different technologies and business solutions gives you plenty of opportunities to use your skills to develop creative solutions.
- Fast Track Your Career: Our training program is designed to give you technical and professional expertise. We tailor our courses so you are fully trained in the relevant technology while continually assessing your skills.
- 401k plan where Qualitest will match your contributions accelerating your savings plan 🇺🇸
- Work hard and play harder with our flexible and casual culture 🇺🇸
- Competitive healthcare benefits: Qualitest will match towards your HSA if you choose to participate 🇺🇸
- Qualitest Tech academy: 3000+ training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs and much more 🇺🇸
- Stay active and get rewarded with our Corporate Wellness Program 🇺🇸
- Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth 🇺🇸
- Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless! 🇺🇸
- Work hard and play harder with our flexible and casual culture 🇨🇦
- Qualitest Tech academy: 3000+ training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs and much more 🇨🇦
- Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth 🇨🇦
- Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless! 🇨🇦
Company HQ
City of London, London, UK
Leadership
Anbu Ganapathi Muppidathi
(President & CEO, not founder)Former SVP and Global Markets Head at Cognizant. Previously a Software Engineer & Educator at various companies.
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