Quality Engineering Lead — CAPA, NPD & Process Control

Katalyst CRO; Arlington (VA); On-site; USD 85,000 - 125,000; Full time

Job summary

Katalyst CRO in Arlington, VA seeks a senior Quality Engineering professional to develop and maintain quality methodologies, systems, and practices that meet regulatory, customer, and internal requirements.

The role provides leadership across design assurance, operations quality, software engineering, supplier assurance, product analysis, metrology, microbiology, and chemistry, mentoring engineers and driving CAPA and process controls.

Qualifications

• 5+ years of experience with a BS in a relevant field.
• 3-4 years of experience with an MS in a relevant field.
• Medical device experience.
• Coordination and ownership, communicating with contract manufacturers and internal Quality/Operations/Design teams, and supporting design changes and supplier corrective actions.

Responsibilities

• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Skills

Leadership

Mentoring

Quality systems

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in field

Master's degree in field

Job description

Katalyst CRO in Arlington, VA seeks a senior Quality Engineering professional to develop and maintain quality methodologies, systems, and practices that meet regulatory, customer, and internal requirements.

The role provides leadership across design assurance, operations quality, software engineering, supplier assurance, product analysis, metrology, microbiology, and chemistry, mentoring engineers and driving CAPA and process controls.