Quality Assurance Lead: Compliance, Audits & Team Growth

Katalyst CRO; El Paso (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Quality Assurance Supervisor to provide direct management of technical staff and support product safety, quality and global regulatory compliance. The role assists the Quality Manager in monitoring quality issues and implementing resolutions while guiding audits and continuous improvement efforts.

The position requires at least a bachelor's degree in science/engineering and a minimum of three years in pharma/medical device manufacturing, with preference for a master's

Qualifications

• Bachelor's degree in Science, Engineering, or related field; master's preferred.
• At least 3 years in pharma/medical device manufacturing, including project leadership.
• Experience in supplier audit programs and corporate initiatives.
• Ability to understand and manage business needs.
• People development skills.

Responsibilities

• Supervise quality activities and compliance programs within focused areas (Supplier Quality, Quality Operations and Project Quality).
• Implement local business organizational goals around quality.
• Identify and address obstacles preventing achievement of goals.
• Ensure the organization is staffed and resourced to fulfill obligations and comply with regulations.
• Supervise, train and mentor quality personnel at the engineering level.
• Assist Quality Manager to support audits (FDA, ISO, audits).
• Participate in blitzes and Six Sigma projects.
• Implement best quality practices.
• Prioritize quality and compliance-oriented solutions.
• Contribute to budget goals by managing department spends.

Skills

Quality leadership

Regulatory knowledge

Bilingual

Auditing

Project leadership

Education

Bachelor's degree in Science/Engineering

Master's degree preferred

Tools

Audit management systems

Job description

Katalyst CRO is seeking a Quality Assurance Supervisor to provide direct management of technical staff and support product safety, quality and global regulatory compliance. The role assists the Quality Manager in monitoring quality issues and implementing resolutions while guiding audits and continuous improvement efforts.

The position requires at least a bachelor's degree in science/engineering and a minimum of three years in pharma/medical device manufacturing, with preference for a master's