Quality Engineer

Job TitleResponsible for development, implementation, and maintenance of Quality System applications and data visualization tools. This role will strategically align with business objectives to develop, implement, and optimize digital solutions that enhance operational excellence across quality and manufacturing processes.The role involves collaborating with cross-functional teams to plan, execute, and document CSV efforts, monitor validated systems, conduct periodic reviews, and manage related investigations. This role will ensure system support and maintenance of applicable business applications and data visualization tools are appropriately established. You will work with our business customers to ensure key technologies are delivering required value to the organization.What You Will DoEnsure application support and management by establishing processes to manage user accounts, permissions, and security policies.Ensure appropriate level of technical assistance is available to users.Ensure process is established to troubleshoot issues and conduct training on new features and system use.Manage the handling of incidents until they are fully resolved, with a detailed analysis of the underlying causes provided.Monitor and maintain these technologies at optimal performance levels.Responsible for gathering requirements and analyzing processes in order to recommend new technologies or improvements existing to quality system applications or data visualization tools.Interpret business requirements to functional designs. Configure and/or partner with external design engineers to configure applications or data visualization tools which align with business requirements.Acts as the principal designer for major systems and their subsystems.Build and maintain multiple DEV, QA and production environmentsCollaborate with key stakeholder on system upgrades and enhancements. Provide input to create a compelling roadmap for new technology and system upgrades.Create and maintain robust and validated processes for making changes.Lead in the planning, development, and implementation of computer systems validation documentation and ensure compliance with required GxP and 21 CFR Part 11 regulations.Provide input in creation and/or review of internal operating procedures.Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to industry standards and federal regulations.Provide support for the Quality Assurance/Operations Departments and to other company departments as directed by Quality Systems Management.Serve as the CSV representative during regulatory inspections.Own the full project lifecycle for software application deployments — from initial scoping through production release — serving as the technical lead and primary escalation point for cross-functional teams.Drive the planning, testing, and implementation of new software capabilities and operational improvements, bringing innovative approaches to complex deployment challenges at the division or business unit level.Manage project scope, budgets, and delivery timelines with rigor, ensuring all milestones are met across directly managed and matrixed teams.Hold accountability for the successful, on-time completion of every task and project under your purview, proactively identifying risks and resolving blockers before they impact delivery.Minimum RequirementsBachelor's Degree in Computer Science and/or Life Sciences5+ years of computer software support and/or related experience5+ Experience in Quality Assurance within medical device/pharma environment and/or related field.Drivers License Upon HirePreferred QualificationsTechnical & Functional SkillsMust be proficient in MS Word, Excel, and PowerPoint software programs.Must have excellent verbal and written communication skills and leadership skills.Ability to work with company staff and communicate effectively throughout the organization is essential.Familiar with industry standards and Federal Regulations.Strong understanding of industry standards and best practices for computer computer validation and assurance such as GAMP 5, 21 CFR Part 11, Annex 11, etc.Experience in application configuration.Strong technical writing and general problem-solving skills.Experience with software quality engineering or QA focused on infrastructure, platform, or DevOps environments (qualification and validation).Familiarity with emerging digital technologies and tools, including AI/ML or advanced data visualization platforms, to support process improvement and decision-making.Experience with owning quality strategy across the full SDLC in distributed, cloud-native systems to drive insights and digital innovation initiatives.BenefitsComprehensive Medical, Dental, and Vision plans20 days of Paid Time Off15 paid holidaysPaid Sick LeavePaid Parental Leave401(k)Employee bonusesAnd more!Your benefits and PTO start the date you're hired with no waiting period!Work Authorization & Visa SponsorshipApplicants must be authorized to work in the United States without the need for employment?based visa sponsorship now or in the future. Merz will not sponsor applicants for U.S. work visa status for this opportunity. No sponsorship is available for any employment?based visas, including but not limited to H?1B, L?1, TN, O?1, E?3, H?1B1, F?1, J?1, OPT, CPT, or any other employment?based visa category.