Quality Control Supervisor

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

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