Quality Control Supervisor

3 hours ago

Fort Worth, Texas, United States Lucid Hearing Full time

Job Description
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
  • 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
  • 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
  • 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
  • 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

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

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