Quality Control Supervisor
About The Position
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
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
- Work with all aspects of regulatory affairs (FDA, OSHA, MDR, TGA, ROHS, REACH, PPE others as applicable)
- 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
- Assist in coordinating corrective/preventive actions, continual improvement, customer complaints and nonconformances and investigating root cause and effectiveness of actions taken
- 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 analyze 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
