QA Leader: Pharma & Medical Device Compliance

Katalyst-Healthcares-; El Paso (TX); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Creative Solutions Services, LLC is seeking a Quality Assurance Supervisor to directly manage technical staff and support the Quality Manager in ensuring product safety, quality and regulatory compliance. The role involves supervising quality activities, audits, training, and driving improvements across supplier, operations, and project quality areas.

The supervisor will help monitor quality issues, support audits (FDA, ISO, etc.), and contribute to resolving compliance challenges while leading

Qualifikationen

• Bachelor's degree in Science, Engineering, or related discipline required.
• Minimum 3 years of pharma/medical device manufacturing experience, incl. leadership.
• Experience managing Supplier Audit programs and corporate initiatives.
• Bilingual English/Spanish preferred.

Aufgaben

• Supervise quality activities and compliance programs in Supplier Quality, Quality Operations and Project Quality.
• Implement local quality goals and drive organizational improvement.
• Identify and resolve obstacles affecting individual impact goals.
• Ensure staffing, organization and resources to meet obligations and procedures.
• Instruct and mentor Quality personnel at the Engineering level.
• Assist Quality Manager with external/internal audits (FDA, ISO, etc.).
• Participate in blitzes, six sigma projects, etc.
• Implement best quality practices and compliant solutions.
• Contribute to budget goals by managing department spends.

Kenntnisse

People development

Bilingual English/Spanish

Ability to travel

Team leadership

Ausbildung

Bachelor's degree in Science/Engineering

Master's degree preferred

Tools

Calibration processes

Quality management systems

Jobbeschreibung

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.