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 process, including but not limited to, conducting incident/issue investigations, assessing risk/impact, conducting trend analyses, and defining and tracking corrective 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 eEvaluates data pertaining to quality events in preparation 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

We are aware that an individual(s) are fraudulently representing themselves as Suvoda recruiters and/or hiring managers. Suvoda will never request personal information such as your bank account number, credit card number, drivers license or social security number — or request payment from you — during the job application or interview process. Any emails from the Suvoda recruiting team will come from a @suvoda.com email address. You can learn more about these types of fraud by referring to this FTC consumer alert. 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.