Onsite QA Deviation & CAPA Senior Specialist

TechDigital Group; Bothell (WA); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Specialist in Quality Assurance to join their Bothell team. This role is crucial for maintaining the highest standards of quality in a regulated cGMP environment. The successful candidate will oversee deviation management and lead investigations, ensuring timely closure and compliance with industry regulations. You will work cross-functionally to support product releases and champion quality initiatives. This position offers the opportunity to make a significant impact on product quality and operational excellence, making it ideal for those passionate about continuous improvement and quality assurance.

Qualifications

• 5-8 years in quality management systems with deviation oversight.
• Bachelor's degree preferred; strong communication skills essential.

Responsibilities

• Manage deviations for timely closure and compliance.
• Lead investigations and facilitate CAPA processes effectively.
• Collaborate cross-functionally to ensure quality standards.

Skills

Deviation initiation and investigations

Cross-functional collaboration

Root Cause Analysis (RCA)

Six Sigma

Kaizen methodologies

Written and verbal communication

Quality management systems

cGMP regulations

FDA/EMA regulations

Education

Bachelor's degree in relevant science or engineering

Associates degree or equivalent

Tools

Electronic quality record management system

Job description

An established industry player is seeking a Senior Specialist in Quality Assurance to join their Bothell team. This role is crucial for maintaining the highest standards of quality in a regulated cGMP environment. The successful candidate will oversee deviation management and lead investigations, ensuring timely closure and compliance with industry regulations. You will work cross-functionally to support product releases and champion quality initiatives. This position offers the opportunity to make a significant impact on product quality and operational excellence, making it ideal for those passionate about continuous improvement and quality assurance.