Quality Control Supervisor

Lucid Hearing Holding Company, LLC•Fort Worth, TX

About The Position

Lucid Hearing is a leading innovator in the field of assistive listening and hearing solutions, and it has established itself as a premier manufacturer and retailer of hearing solutions with its state-of-the-art hearing aids, testing equipment, and a vast network of locations within large retail chains. As a fast-growing business in an expanding industry, Lucid Hearing is searching for passionate people to add to our family of associates. Works closely with Department Managers in prioritizing timely completion of product QC, problem-solving, issues, regulatory affairs etc. Trains new and existing personnel, on OSHA and FDA guidelines and the ISO quality management system. 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, implement and assist in the activities of the Quality Control Department Implementing and maintaining the DHR’s in the quality system Will be responsible for assisting in coordinating corrective/preventive actions, continual improvement, customer complaint nonconformances and SCARS and investigating root cause and effectiveness of actions taken Must work with all aspects of regulatory affairs (FDA, OSHA, MDR, ROHS, REACH, PFAS, others as applicable) and help the organization make appropriate decisions regarding regulatory affairs Working knowledge of medical device and PPE regulations to assist organization in making appropriate decisions to maintain compliance. Works to ensure process and procedures are controlled, accurate in reflecting the current process and meet expectations as defined ISO policy Assist in Quality Management System audits, internal, external, customer and supplier audits 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 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 QC/QMS/ISO/Regulatory experience

Responsibilities

coordinate, implement and assist in the activities of the Quality Control Department
Implementing and maintaining the DHR’s in the quality system
assisting in coordinating corrective/preventive actions, continual improvement, customer complaint nonconformances and SCARS and investigating root cause and effectiveness of actions taken
work with all aspects of regulatory affairs (FDA, OSHA, MDR, ROHS, REACH, PFAS, others as applicable) and help the organization make appropriate decisions regarding regulatory affairs
ensure process and procedures are controlled, accurate in reflecting the current process and meet expectations as defined ISO policy
assist in Quality Management System audits, internal, external, customer and supplier audits
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 analyzes 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
keep up on standards, regulations/laws, issues, and news with respect to product (service) quality
additional duties as assigned