Systems Engineer - RAQA

Description

We are looking for a Systems Engineer III to support product issue management and backlog coordination for related product lines in Raleigh, North Carolina. This long-term position focuses on driving investigations, aligning cross-functional stakeholders, and helping teams meet program objectives for both existing products and new development efforts. The role works closely with partners across engineering, quality, regulatory, operations, medical affairs, sales, service, and marketing to clarify requirements, resolve product concerns, and maintain strong documentation practices.

Responsibilities:
Lead structured reviews of reported product problems by partnering with technical experts to identify root cause and next steps.
Evaluate each issue for business and product impact, including severity, affected users, connected systems, occurrence patterns, and impacted versions.
Establish reliable reproduction methods for reported anomalies and capture any interim controls or workarounds already in use.
Record the potential risk of unresolved issues and ensure gaps in risk documentation are directed to the appropriate owner for action.
Oversee intake and triage of newly submitted issue records, closing duplicate entries with clear justification and advancing unique findings for deeper analysis.
Produce accurate, audit-ready records that summarize investigation results, supporting evidence, decisions, and final disposition.
Maintain complete and factual quality documentation in the designated tracking system, ensuring all required fields are addressed appropriately.
Coordinate cross-functional timelines, follow up on commitments, and escalate concerns when delivery targets or budget expectations are at risk.
Raise urgent product concerns for formal review when they affect safety-related requirements, risk controls, or approved label claims.

Requirements

Bachelor's degree in Engineering or a related discipline, or equivalent practical experience, with at least 5 years of relevant industry experience.
Background in a regulated environment such as medical device, pharmaceutical, or automotive is strongly preferred.
Strong written and verbal English communication skills with the ability to present information clearly across multiple teams.
Demonstrated ability to work independently, stay organized, and manage priorities with limited supervision.
Experience developing practical solutions to technical or process-related issues in a fast-paced setting.
Proficiency with Microsoft Office applications and disciplined documentation practices.
Ability to collaborate effectively with cross-functional stakeholders while maintaining accountability for deadlines and deliverables.
Adaptable, self-motivated individual with strong time-management skills and a consistent focus on quality and completion.

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