Team Leader, Quality Assurance

Summary:  Responsible for

• establishing and maintaining an Ultraflex quality management system that promotes customer satisfaction and continuous improvement by delivering right, on-time, the first time.
• promoting a safe working environment through awareness and training to applicable standards.

Responsibilities:

• Oversee implementation and maintenance of Ultraflex QMS which conforms to the ISO 13485 and 9001 quality standards and FDA QSR.  
• Serve as the primary quality control resource for problem identification, resolution, and continuous improvement via CAPA process.
• Serve as official FDA correspondent
• Support the design, documentation and implementation procedures for process control, process improvement, testing and inspection as required.
• Establish collection and analysis systems of statistical data to predict trends that will affect product quality via COPQ reports.
• Assist in monitoring vendor performance.
• Report to management on quality issues, trends, and losses.
• Participate in internal and external quality audits.
• Oversee and assure compliance to document control, record control, and change processes
• Identify company safety training needs and develop and coordinate safety training programs.
• Develop annual company quality and safety goals.
• Participate in new product/process reviews
• Maintain corporate safety library (e.g. videos, regulations, reference manuals).
• Review process operating procedures/batch records and provide input for safety and health considerations.
• Understand Federal and State (Pennsylvania) occupational safety and health regulations and monitor regulatory changes (through Federal Register, etc.) as they occur.
• Provide technical support to corporate and plant personnel to ensure compliance with applicable quality system and / or occupational safety and health regulations.
• Advise staff of regulatory changes with which Ultraflex must comply.
• Periodically audit practices and records of manufacturing staff to ensure compliance with company programs and Federal/State occupational safety, health, and FDA regulations.
• Other duties in the interest of the Company as needed or assigned.

Qualifications:

• Bachelor’s degree with a minimum of 2 years quality related experience; or Associates degree with 4 years of quality related experience; or a minimum of 5 years of quality related experience.
• Knowledge of Quality System requirements.
• Knowledge of ISO 9000 requirements with some knowledge of aerospace requirements (AS9100, D1-9000, etc.).
• Working knowledge of computers including word processing, spreadsheets and databases.
• Excellent communication skills (written and verbal).
• Ability to communicate effectively, make presentations and write concise reports for all levels of employees.
• Diverse knowledge of inspection and control methods, techniques and documentation.
• Strong computer skills including quality control applications, word processing, spreadsheets and databases.
• Thorough understanding of general safety requirements.