JOB DESCRIPTION: (QUICK SUMMARY OF THE ROLE)   

Responsible for managing and monitoring the quality activities of manufacturing, supplier and customer operations. Acts as the management representative to oversee the quality management systems in the facility.  Oversees QA personnel to ensure the attainment of goals set for overall quality assurance/control systems, quality managements systems/documentation, and overall quality reactive and proactive activities are met for the Dallas site.  

RESPONSIBILITIES (LIST OF ACTIVITIES FOR THE ROLE):  

• Plans, coordinates, and directs quality assurance/control programs and help establish standards designed to ensure continuous production of products by performing duties. 

• Appointed as a management representative who has the authority and responsibility in implementing and maintaining the quality management system and report to top management on the performance of the QMS as needed.  

• Review and evaluate inputs related to the Quality Management System for compliance and trends 

• Directly supervise the Quality Team; manages department and overall expectations pertaining to priorities, budget, costs and resources; establish and maintain policy for documentation of all products. 

• Audits production facility to ensure compliance with applicable international standards and regulatory requirements, ISO 13485, ISO 22716, ISO 14971, QSR – 21 CFR 810, and GMP’s – 21 CFR 210/211. 

• Monitor and advicing the performance of the site quality management system, producing data, and measuring quality operations against set standards. 

• Review products, processes and systems on an ongoing basis to determine where improvements can be made; works with Quality, Supply Chain and operations to establish procedures, standards, and systems. 

• Work with Supply Chain and external suppliers to establish quality requirements for materials and components; works with operations and engineering to establish procedures, specifications, standards, and systems. 

• Manage the selection and development of people, resources, and budgets necessary to perform the functions of the department; trains workforce as required in various quality methods, standards and procedures. 

• Ensures Quality system effectiveness and conformance to industry standards and applicable international and regulatory requirements; Reports to management on the effectiveness of the quality system. 

Qualifications: 

Required Education & Skillsets:    

• Must have a Bachelor’s degree (B.A/B.S.) in a technical field; chemistry preferred. 

• Minimum of 10 to 12 years applicable/related experience in a decision making role for the Medical Device Industry, OTC Drug and Cosmetic product.  Preference some experience with liquid fill products – lotions, creams, gels, powders in Liquid Manufacturing sites. 

• Must be able to present projects, findings, to a large group and interface with the group. 

• Must have strong experience with writing procedures and standards; experience in Quality Assurance and Quality Control. 

• Excellent problem solving, analytical skills and risk & crisis management. 

• Must have excellent communications skills with internal and external customers. 

• Knowledge of Validation (IQ, OQ, PQ) for Cleaning, Class 1/Class II Medical Devices, OTC Drug and Cosmetic products. 

• Experience managing a large staff. 

• Must have experience and knowledge of ISO 13485, ISO 14971 and 22716, 21CFR 820, 210/211 and cGMP; Sterilization; lab testing – physical, analytical and micro. 

• New Product Development (Formulation Technology Transfer) and Design Control 

• Hosting FDA, ISO and Customer Audits; Water Systems, Environmental Monitoring, Stability programs; MAV, AQL, and Annual Product Reviews.  

• Self- motivated professional, driven individual with a strategic mindset.  

Preferred (Preferred, but not legally required for hire) 

• Bilingual (Spanish) preferred.