Garware Fulflex Texas

FulFlex ProTech

Position Summary

The ProTech III is responsible for performing in-process and final product inspections throughout molding and related manufacturing operations to ensure compliance with quality, regulatory, and customer requirements. Working with minimal supervision, this role samples, inspects, tests, and documents product quality attributes while supporting production efficiency and compliance with established manufacturing standards.

The ProTech III serves as a certified quality representative within the production environment and is responsible for product disposition decisions, documentation review, and communication of quality concerns to production and quality leadership. This position plays a critical role in maintaining product quality, supporting continuous improvement initiatives, and ensuring adherence to Good Manufacturing Practices (GMP) and company procedures.

Reporting Relationships

Reports To: Production Supervisor

Functional Guidance From:

• Mold Technician
• Quality Specialist
• Manufacturing Leadership

Supervisory Responsibility: None

Work Environment

This position supports manufacturing operations that may include:

• Injection molding
• Extrusion
• Blow molding
• Assembly operations
• Secondary processing and packaging activities

Operations may run continuously in a multi-shift environment, including weekends, to manufacture medical devices and related products. The ProTech III routinely works on the production floor and interacts with production, quality, and technical personnel.

Key Responsibilities

Quality Inspection and Product Evaluation

• Perform sampling activities in accordance with approved sampling plans and inspection procedures.
• Conduct visual, functional, dimensional, and labeling inspections on in-process and finished products.
• Utilize measuring and testing equipment including micrometers, gauges, calipers, and other inspection tools to verify product conformance.
• Evaluate products against engineering drawings, specifications, work instructions, and quality standards.
• Accurately document inspection and testing results in accordance with established procedures and regulatory requirements.
• Determine and document the disposition status of assigned product lots and production batches within authorized limits.

Production Support

• Monitor assigned work orders and production activities to ensure compliance with Standard Production Methods (SPMs), work instructions, and quality requirements.
• Support production operations by assisting with operator breaks, lunches, and coverage needs as directed.
• Assist with product handling, sorting, rework, containment activities, and departmental housekeeping as needed.
• Communicate process, tooling, equipment, or quality concerns promptly to the Mold Technician, Production Supervisor, or Quality representative.

Documentation and Compliance

• Review Device History Records (DHRs), work orders, and associated documentation for completeness, accuracy, and compliance with company and regulatory requirements.
• Verify that correct materials, components, labels, and process parameters are being utilized during production.
• Maintain acceptable documentation accuracy rates as established by quality performance metrics.
• Ensure activities comply with applicable quality management system requirements, GMP regulations, ISO standards, and company procedures.

Problem Identification and Escalation

• Identify product nonconformances, process deviations, and documentation discrepancies.
• Notify appropriate production and quality personnel when quality issues are detected.
• Escalate unresolved issues through established channels when corrective actions are ineffective or not implemented.
• Assist in containment, investigation, and corrective action activities as requested.

Continuous Improvement and Safety

• Participate in continuous improvement initiatives, Kaizen events, Lean Manufacturing activities, and problem-solving teams.
• Support cost reduction efforts through waste elimination, process improvements, and operational efficiencies.
• Maintain a clean, organized, and safe work environment.
• Follow all environmental, health, and safety policies and proactively identify potential workplace hazards.

Knowledge Requirements

The ProTech must possess working knowledge of:

• Quality inspection techniques and product acceptance criteria
• Manufacturing processes related to molding, extrusion, assembly, and medical device production
• Sampling plans and statistical inspection methods
• Good Manufacturing Practices (GMP)
• Device History Records (DHR)
• Device Master Records (DMR)
• Product Control and Lot Traceability requirements
• Production Work Orders
• Standard Production Methods (SPM)
• Engineering drawings and part prints
• Quality Management System requirements
• Continuous improvement methodologies, including Lean Manufacturing principles

Skills and Abilities

• Strong attention to detail and commitment to quality.
• Ability to make sound product disposition decisions based on established criteria.
• Effective written and verbal communication skills.
• Ability to manage multiple priorities and active work orders simultaneously.
• Proficiency in completing production and quality documentation accurately.
• Ability to work collaboratively with operators, technicians, supervisors, and quality personnel.
• Ability to use measuring and inspection equipment accurately.
• Basic computer skills, including data entry and electronic document systems.
• Ability to train and mentor operators and developing ProTech personnel on quality standards and manufacturing requirements.

Leadership and Training Responsibilities

• Serve as a quality resource for production personnel.
• Assist in training and coaching Operators and ProTech team members on:
  • Quality standards
  • Inspection techniques
  • GMP requirements
  • Documentation practices
  • Lean manufacturing principles
  • Continuous improvement methodologies
• Promote a culture of quality, safety, accountability, and operational excellence.

Minimum Qualifications

Education

• High School Diploma or GED required.

Experience

• Minimum of 2 years of manufacturing, quality inspection, or medical device production experience preferred.
• Previous experience in molding, extrusion, assembly, or regulated manufacturing environments preferred.

Training Requirements

• Completion of Fulflex Manufacturing Competency Training or equivalent Quality Awareness Program.
• Qualification and certification in applicable inspection and product disposition processes.
• Training on applicable quality system, safety, and regulatory requirements.

Physical Requirements

• Ability to stand and walk for extended periods.
• Ability to lift and move materials up to established company limits.
• Ability to perform visual inspections with or without corrective lenses.
• Ability to use precision measuring instruments and perform repetitive tasks.

Core Competencies

• Quality Focus
• Attention to Detail
• Accountability
• Communication
• Teamwork and Collaboration
• Continuous Improvement
• Problem Solving
• Regulatory Compliance
• Customer Focus
• Adaptability

Fulflex is an equal opportunity employer committed to maintaining a safe, inclusive, and high-performing workplace dedicated to delivering quality products and exceptional customer satisfaction.