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

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 QC/QMS/ISO/Regulatory experience

All your information will be kept confidential according to EEOC guidelines.