Quality Engineer (Systems & Compliance)

OpenKrill; United States; Remote; USD 75,000 - 120,000; Full time

Job summary

Suvoda is seeking a Quality Engineer to support quality assurance activities, improve processes, and ensure product quality and compliance across teams. You will investigate Quality Events, perform root cause analyses, and drive corrective actions in a GxP environment.

You’ll develop KPIs, prepare client-facing reports, and collaborate with multiple functions to deliver high-quality results and continuous QMS improvement. Strong writing and English proficiency are essential.

Qualifications

• Bachelor’s degree in science-related field preferred.
• High-achieving personality.
• Desire to learn, grow, and develop.
• Strong work ethic and sense of ownership.
• 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; Proficient in English.
• Knowledge of Process Improvement techniques preferred.

Responsibilities

• Manages and facilitates all stages of the Quality Event Management process, including incident investigations and CAPA actions.
• Conducts root cause analyses and applies CAPA for corrective actions.
• Performs quality event trend reviews and escalation to QA when warranted.
• Produces client-facing investigation reports and communicates progress to stakeholders.
• Conducts risk assessments and impact analyses for investigations.
• Attends weekly Issue Management Team meetings and prepares slides.
• Prepares data for audits and drives cross-functional process improvements.
• Develops and maintains KPIs and analyzes data to support QMS improvements.
• Develops SOPs, Work Instructions, Guidelines and knowledgebase articles; revises existing ones.
• Creates internal reports using Excel and PowerPoint.

Skills

Analytical thinking

Attention to detail

Time management

Ownership

Proactive attitude

Communication

Technical writing

English proficiency

Education

Bachelor’s degree in science-related field

Job description

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

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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.