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Lucid Hearing · 1 day ago

ISO & Regulatory/Quality Management Systems Supervisor

Fort Worth, TX, USA

Full-time

Onsite

Senior Level

5+ years exp

Lucid Hearing is a company in the Health, Wellness, and Fitness industry, seeking an ISO & Regulatory/Quality Management Systems Supervisor. The role involves coordinating activities to ensure the manufacturing facility's Quality Management System meets ISO and regulatory requirements, while providing leadership for audits and training personnel on quality management processes.

ElectronicsMedical Device

Responsibilities

Coordinate the activities to ensure the manufacturing facility Quality Management System is meeting ISO and country requirements

Maintaining and updating the Quality Management System

Functions as the location ISO/Quality Management Representative

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

Participate in the coordination and execution of Operations Quality Management System

Ensure process and procedures are controlled, accurate in reflecting the current process and meet expectations as defined ISO policy

Provide leadership for Quality Management System audits, internal, external, customer and supplier audits

Ensure compliance to the Quality Management Systems, assist in establishing and coordinating required documentation

Assist in coordinating corrective/preventive actions, continual improvement, customer complaints and nonconformances and investigating root cause and effectiveness of actions taken

Maintain accurate and complete personnel training records as it relates to the Quality Management System for Elk Grove Village and outsourced processes. Ensure that rules concerning confidentiality and retention are followed

Participate in the External Audits for ISO Certification and other certification organizations

Report out on ISO findings; review 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

Plan and coordinate new Associate orientation as it relates to Quality Management System

Responsible for training on changes in QMS processes

Oversee product recalls

Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality

Additional duties as assigned

Qualification

ISO 9001ISO 13485Quality Management SystemRegulatory AffairsQuality Auditor CertificationAnalytical SkillsMicrosoft SuiteProblem SolvingLeadership SkillsCommunication Skills

Required

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