Job Description

SUMMARY

The Production Supervisor leads daily manufacturing operations for catheter based medical devices in a regulated environment. This role is responsible for supervising production personnel, ensuring strict adherence to Quality System Regulations and GMP requirements, and driving operational performance across safety, quality, delivery, and cost. The Production Supervisor supports both commercial and pilot manufacturing activities while fostering a culture of accountability, compliance, and continuous improvement.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Manufacturing Operations

1. Supervise daily production activities to ensure catheter assemblies are manufactured in accordance with approved work instructions, manufacturing records, and quality standards.

2. Manage staffing, scheduling, and workflow to meet production targets while maintaining efficiency and product quality.

3. Coordinate equipment, materials, and personnel to support commercial and development manufacturing.

4. Participate in Demand Planning meetings and translate production plans into executable work orders.

5. Monitor manufacturing performance metrics, including output, yield, scrap, and downtime, and take appropriate corrective actions.

Quality & Compliance

1. Comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) at all times.

2. Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and internal quality system requirements.

3. Review and approve manufacturing documentation for accuracy, completeness, and regulatory compliance.

4. Support internal, customer, and regulatory audits. Participate in investigations, nonconformances, and CAPA activities as required.

People Leadership

1. Lead, coach, and develop a team of assemblers and technicians in a catheter manufacturing environment.

2. Ensure all production personnel are properly trained, qualified, and documented for assigned manufacturing processes.

3. Monitor and maintain employee training records.

4. Provide regular performance feedback, support employee engagement, and address personnel matters professionally and consistently.

Continuous Improvement & Safety

1. Identify and implement opportunities to improve manufacturing efficiency, product quality, and workplace safety.

2. Support root cause analysis and corrective actions related to manufacturing or quality issues.

3. Promote a safe work environment and ensure compliance with all safety and environmental policies.

4. Proactively identify and address unsafe conditions or behaviors.

EXPERIENCE REQUIREMENTS

1. A minimum of 5 years of medical device manufacturing.

2. 2+ years of supervisory or team lead experience in production or operations.

EDUCATION REQUIREMENTS

1. High school diploma or equivalent.

2. Associate or Bachelor's degree in Manufacturing, Engineering, or related field preferred.

OTHER QUALIFICATIONS

1. Strong understanding of GMP, GDP, and regulated manufacturing requirements.

2. Experience with catheter or precision medical device assembly (e.g., bonding, soldering, heat fusing, testing).

3. Ability to read and interpret manufacturing instructions, drawings, and technical documentation.

4. Strong leadership, communication, and problem solving skills.

5. Experience with ERP/MRP systems or electronic manufacturing records.

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