ISO & Regulatory/Quality Management Systems Supervisor

Lucid Hearing Holding Company, LLC•Fort Worth, TX

About The Position

Works closely with Department Mangers in problem-solving, issues, regulatory affairs etc. Trains new and existing personnel, on OSHA and FDA guidelines and the ISO quality management system. Maintains the quality management system and is the quality management representative in the Elk Grove facility; while supporting the Elk Grove Village, IL facility. Summary of Essential Job Duties: An individual must be able to successfully perform the essential functions of this position with or without a reasonable accommodation. Primary responsibility will be to coordinate the activities to ensure the manufacturing facility Quality Management System is meeting ISO and country requirements Maintaining and updating the Quality Management System Functions as the location ISO/Quality Management Representative Must work with all aspects of regulatory affairs (FDA, OSHA, MDR, TGA, ROHS, REACH, PPE others as applicable) and help the organization make appropriate decisions regarding regulatory affairs Activities to include but not limited to: Participate in the coordination and execution of Operations Quality Management System Works to ensure process and procedures are controlled, accurate in reflecting the current process and meet expectations as defined ISO policy Provides leadership for Quality Management System audits, internal, external, customer and supplier audits Ensures compliance to the Quality Management Systems, assist in establishing and coordinating required documentation Will be responsible for assisting in coordinating corrective/preventive actions, continual improvement, customer complaints and nonconformances and investigating root cause and effectiveness of actions taken Maintain accurate and complete personnel training records as it relates to the Quality Management System for Elk Grove Village and outsourced processes. Ensures that rules concerning confidentiality and retention are followed Participates in the External Audits for ISO Certification and other certification organizations Reports out on ISO findings; reviews ISO corrective actions/preventative actions (CAPAs) Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records Working with Product Development/Management, associates, contractors, and outsourcing firms to develop product requirements Assist in conducting quarterly management meetings and prepare reports Plans and coordinates new Associate orientation as it relates to Quality Management System Responsible for training on changes in QMS processes Oversee product recalls Keeps up on standards, regulations/laws, issues, and news with respect to product (service) quality Additional duties as assigned

Requirements

Excellent organizational and follow-up skills
Detailed oriented individual with high energy level
Strong problem solving and analytical skill sets
Ability to conceptualize interactions of process with regards to integrating for a effective and efficient quality management system as it relates to the organizations goals
Self-motivated with a strong sense of urgency
Excellent communication skills oral and written
Ability to multi-task, organize and prioritize ongoing projects
Ability to treat confidential information with sensitivity
Must be assertive, objective, and participate and able to work with all levels of Associates
Must be flexible with work schedule
Must be able to travel
Strong leadership skills with the ability to drive the continual improvement process within the organization
Strong commitment to quality
Microsoft Suite – advanced skills in Excel
Ability to work in a fast pace environment
BS/BA in Business Administration, Quality Control Engineer
5 or more years’ experience QMS/ISO/Regulatory experience
Certified ISO 9001, ISO 13485 or Quality Auditor Certification CQA

Responsibilities

Coordinate activities to ensure the manufacturing facility Quality Management System is meeting ISO and country requirements
Maintain and update the Quality Management System
Function as the location ISO/Quality Management Representative
Work with all aspects of regulatory affairs (FDA, OSHA, MDR, TGA, ROHS, REACH, PPE others as applicable)
Participate in the coordination and execution of Operations Quality Management System
Ensure process and procedures are controlled, accurate in reflecting the current process and meet expectations as defined ISO policy
Provide leadership for Quality Management System audits, internal, external, customer and supplier audits
Ensure compliance to the Quality Management Systems, assist in establishing and coordinating required documentation
Assist in coordinating corrective/preventive actions, continual improvement, customer complaints and nonconformances and investigating root cause and effectiveness of actions taken
Maintain accurate and complete personnel training records as it relates to the Quality Management System for Elk Grove Village and outsourced processes
Participate in the External Audits for ISO Certification and other certification organizations
Report out on ISO findings; reviews ISO corrective actions/preventative actions (CAPAs)
Evaluate and analyze the efforts in organizing, documenting and interpreting inspection support documents and records
Work with Product Development/Management, associates, contractors, and outsourcing firms to develop product requirements
Assist in conducting quarterly management meetings and prepare reports
Plan and coordinate new Associate orientation as it relates to Quality Management System
Responsible for training on changes in QMS processes
Oversee product recalls
Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality
Additional duties as assigned