Quality Engineer - RCA, CAPA & Process Improvement

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 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.