Plant Quality Manager

GCX Healthcare Solutions • El Paso, TX

5d

About The Position

The Plant Quality Manager is responsible for leading all quality activities at the El Paso manufacturing site, ensuring compliance with ISO 13485 and internal quality requirements while maintaining a strong focus on efficiency, timely execution, and operational flow. This role owns site-level quality execution, including inspection oversight, MRB and return processing, investigations, and corrective actions, and serves as the primary quality escalation point for the plant.

Requirements

• Bachelor’s degree (B.S.) in an Engineering, Technical, or Scientific field preferred.
• Minimum of 8 years of relevant experience, or advanced degree with minimum of 6 years relevant experience
• Minimum of 2 years of managerial experience.
• Working knowledge of ISO 13485 and regulated manufacturing environments.
• Strong understanding of quality tools and methodologies (CAPA, NCR, MRB, root cause analysis).
• Ability to balance compliance requirements with operational efficiency.
• Strong leadership, communication, and decision-making skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

Responsibilities

• Provide site-level leadership for all QC and QA activities across shifts, with a strong focus on efficiency, timely execution, and flow.
• Manage QC Leads (1st and 2nd shift), QA personnel, and the MRB Coordinator; ensure appropriate training and competency of QC/QA staff.
• Own plant-level nonconformance management, MRB activities, and return (RMA) processing, ensuring timely review, disposition, and documentation.
• Lead or support root cause investigations and CAPA to prevent recurrence of quality issues.
• Coordinate QC/QA activities to meet production and customer commitments on time.
• Monitor, analyze, and report key site quality metrics (NCMR, MRB aging, returns, scrap, CAPA) and drive actions to address adverse trends.
• Ensure QC/QA records, DHRs, and related documentation comply with ISO 13485, cGMP, and GDP requirements.
• Participate in internal and external audits and support audit readiness and follow-up actions.
• Serve as the Quality representative on the Plant Leadership Team and in cross-functional initiatives.
• Travel requirements: Limited

What This Job Offers

• Job Type: Full-time
• Career Level: Manager