Quality Engineer - CAPA & GxP Risk Analyst

OpenKrill; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

Suvoda is seeking a Quality Engineer to join our team and help ensure the quality, reliability, and performance of our solutions. You will collaborate with cross-functional teams to support QA activities, identify improvement opportunities, and deliver high-quality products that meet standards and customer expectations.

Responsibilities include leading Quality Event Management, root cause analyses, risk assessments, and KPI development to support continuous improvement within a GxP-oriented

Qualifications

• Bachelor's degree required or equivalent in a science-related field.
• Analytical thinker with strong attention to detail and ownership.
• Familiarity with quality systems and documentation practices.

Responsibilities

• Manages and facilitates Quality Event Management processes including investigations and CAPA actions.
• Performs root cause analyses using RCA tools and communicates findings to stakeholders.
• Conducts risk assessments and impact analyses for Quality Event Investigations.
• Prepares client-facing and internal reports to share investigation status and outcomes.
• Maintains KPIs and drives continuous improvement of the QMS.
• Develops SOPs, work instructions, and knowledgebase articles for process improvements.
• Produces slides and notes for weekly Issue Management Team meetings.

Skills

Analytical thinking

Attention to detail

Time management

Communication skills

Risk assessment

Proactive attitude

English proficiency

GxP knowledge

Education

Bachelor’s degree in science-related field

Tools

Excel

PowerPoint

Job description

Suvoda is seeking a Quality Engineer to join our team and help ensure the quality, reliability, and performance of our solutions. You will collaborate with cross-functional teams to support QA activities, identify improvement opportunities, and deliver high-quality products that meet standards and customer expectations.

Responsibilities include leading Quality Event Management, root cause analyses, risk assessments, and KPI development to support continuous improvement within a GxP-oriented