Quality Assurance Supervisor

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

Summary The Quality Assurance Supervisor will provide direct management of technical staff. The Quality Assurance Supervisor contributes to the execution of the tactics required to achieve departmental objectives. The Quality Assurance Supervisor is key in assisting the Quality Manager in ensuring product safety, quality and compliance with all relevant global regulations and customer expectations. They will also assist in monitoring frequency and scale of quality and organizational issues and in offering resolutions to these issues.

Summary The Quality Assurance Supervisor will provide direct management of technical staff. The Quality Assurance Supervisor contributes to the execution of the tactics required to achieve departmental objectives. The Quality Assurance Supervisor is key in assisting the Quality Manager in ensuring product safety, quality and compliance with all relevant global regulations and customer expectations. They will also assist in monitoring frequency and scale of quality and organizational issues and in offering resolutions to these issues.

Responsibilities

• Supervise quality activities and compliance programs within specific focused areas (Supplier Quality, Quality Operations and Project Quality).
• Implement local business organizational goals; specifically around quality.
• Proactively identify and work through obstacles that may hinder associates from focusing on and delivering their individual impact goals.
• Ensure her/his organization is staffed, organized and resourced to fulfill its obligations and to comply with applicable regulations and procedures.
• Supervise/Train / mentor Quality personnel at the Engineering Level.
• Assist Quality Manager to support external/internal audits (FDA, ISO, Segment Audits, Customer Audits, etc.)
• Participate as team members on blitzes, six sigma projects, etc.
• Implement best quality practices.
• Prioritize quality and compliance minded solutions for her/his area of responsibility
• Contributes to the attainment of budget goals by managing department spends

Education And Experience

• Minimum of a bachelor's degree in Science, Engineering, or other relevant discipline; master's degree preferred.
• Minimum of three (3) years of relevant technical experience in a pharma or medical device manufacturing environment (including project leadership).
• Experience in managing Supplier Audit programs and deployment of corporate initiatives.
• Ability to clearly understand and manage business needs.
• People development skills.

Knowledge And Skills

• Knowledge of managing incoming inspection process for complex parts.
• Knowledge of calibration processes and standards preferred.
• Ability to travel as needed.
• Bilingual (English/Spanish) preferred.