#11131 - Compliance Quality Engineer
Atlanta, Georgia, United States - Remote
Are you interested in working with the World’s leading AI-powered Quality Engineering Company?
Qualitest is looking for a Software Quality Engineer to join our growing Healthcare team.
We are seeking a highly skilled Software Quality Engineer to join our Compliance Team in a fast-paced and innovative biotech company. This role will be pivotal in ensuring that our software engineering processes, IT operations, and overall company practices adhere to FDA regulations, security standards, and other relevant industry standards and guidelines. 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. In addition, risk management activities will also be an integral part of the job duties for this role.
Note: This role does not relate to software QA testing professionals, although such experience may be helpful in this oversight rolex`
Key Responsibilities and Essential Functions
- 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.
- 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.
- Be a part of a company who strives to support for diversity and inclusion in the workplace – we are one, we are many at Qualitest. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences.
- Local and global opportunities – we offer you internal rotation and international mobility opportunities to grow your career.
- Clear view of your career and progression with the company – Qualitest is growing massively (since Jan 2021 – added more than 2000 engineers) and giving you the opportunity to grow with us.
- Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.
- Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan.
- Take care of health with enrollment into one of our competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate.
- Never stop experimenting and learning with Qualitest Tech academy: Tuition Reimbursement Program, 3000+ training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs and much more
- Stay active and get rewarded with our Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym!
- We invest in our Senior Engineers and leaders with our Equity 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!
Intrigued to find more about us?
- Visit our website at www.qualitestgroup.com
- Check out our Career page: https://qualitestgroup.com/careers
If you like what you have read, send us your resume and let’s start talking!
* Salary range is an estimate based on our InfoSec / Cybersecurity Salary Index 💰
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