An individual must be able to successfully perform the essential duties of this position with or without a reasonable accommodation.  

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.  

This role is based in Fort Worth, TX.

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  

Skills/Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• 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  

Education, Certificates, Licenses, Registrations: 

• 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 

We are an Equal Employment Opportunity Employer.