Quality Engineer (Systems & Compliance)

Suvoda is looking for a Quality Engineer to join our team and help ensure the quality, reliability, and performance of our solutions. In this role, you’ll collaborate with cross-functional teams to support quality assurance activities, identify opportunities for improvement, and contribute to delivering high-quality products that meet our standards and customer expectations.

Responsibilities:

Manages and facilitates all stages of the Quality Event Management pro cess, including but not limited to, conducting incident /issue investigation s , assessing risk/ impact , conducting trend analyses , and defining and tracking c orrective and preventive actions and associated effectiveness checks .

Conducts Quality Event Investigations by facilitating and completing root cause analyses: working internally with cross-functional teams to collect and analyze relevant data, utilizing and applying RCA tools (such as flowcharts, fish bone diagrams, 5-Why's analysis, etc.) and ensuring that investigations are conducted in accordance with a GCP-regulated environment. Applies CAPA disciplines to develop effective corrective and preventive action plans .

Performs quality event trend reviews and facilitates analyses , escalating observations when deemed warranted by QMS process.

Produces client-facing documents/communications, such as Quality Event Investigation Reports; adapting highly technical investigation details for a non-technical audience and communicating investigation progress updates to stakeholders when needed.

Conducts risk assessments and facilitates impact analyses in response to Quality Event Investigations.

Attends weekly Issue Management Team meetings. Prepares slides for the meetings, takes notes during meetings, and follows up on actions from the meeting, as required.

Prepares and e E valuates data pertaining to quality events in prepar ation of audits and in response to audit findings , working and works cross functionally with teams to implement process improvements as needed .

Develops and maintains key performance indicators (KPIs) and calculates performance based on data from available sources to support the continuous improvement of the quality management system.

Works with teams to develop new processes in the form of SOPs, Work Instructions, Guidelines, Forms, Templates and knowledgebase articles. Likewise, performs reviews and revisions of current processes in the form of SOPs, Work Instructions, Guidelines, Forms, Templates and knowledgebase articles to ensure continuous improvement of the Quality Management System.

Creates internal reports for stakeholders that provide insight and value regarding product and process performance and/or the status of Quality Event Investigation activities using a combination of Excel and PowerPoint.

Requirements:

Bachelor’s degree in science-related field preferred

High-achieving personality

Desire to learn, grow, and develop

Strong work ethic and sense of ownership

Highly analytical with fine attention to detail

Proactive attitude

Strong time management and organization skills

Ability to practice risk-based judgement

Excellent oral and written communication skills and technical writing capabilities; Proficient in English.

Knowledge of Process Improvement techniques preferred

Experience:

1-3 years of experience in a GxP compliance and /or quality-related role preferred

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As set forth in Suvoda’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

If you are based in California, we encourage you to read this important information for California residents linked here .