Job Title:  Quality Assurance Manager

Job Summary

The Quality Assurance Manager is responsible for establishing, implementing and maintaining an effective quality system that assures processes are followed and documented in relation to ISO standards, customer and company requirements. This role will provide leadership to a team that is committed to doing things right the first time, in order to deliver high quality products with superior sololutions and service. 

Essential Duties and Key Responsibilities

• Develops and implements quality systems and practices to assure compliance with FDA, ISO and other required regulatory bodies. Interfaces with regulatory bodies as Quality Management Representative.
• Responsible for safe operation of all quality processes. Identifies improvements needed and leads project for implementation. 
• Effectively communicates to all levels of the organization through daily operational meetings, weekly staff meetings, quarterly business reviews, and other mechanisms as determined.
• Monitors and measures the quality team performance to ensure continuous improvement through commonly accepted metrics. 
• Utilizes TQM to define the quality organization and systems. Manage the development and implementation of goals, metrics, objectives, policies, procedures and systems. 
• Identifies and delivers quality related organization wide training needs and develop programs.  
• Develops customer and internal inspection based metrics.  Identifies trends and develops action plans.
• Monitors supplier quality performance and initiates programs to ensure suppliers meet organization and customer expectations.
• Coordinates customer non-conformance responses.
• Assists in program launch, process qualifications and equipment validations.
• Develops and evaluates measurements including conducting MSA, developing complex measurements systems, implementing sampling strategies and control plans.
• Develops, implements, and executes a comprehensive gage control plan.
• Benchmark industry best practices.  Develop and implement programs to promote excellence. Ensures compliance with national and international standards and legislation.
• Provides leadership and supervision to quality technical staff to ensure technical excellence.  
• Executes plan to enhance profitability, productivity and efficiency throughout the quality department.  

Education and/or Experience

• Bachelor's degree (B.S.) in Mechanical Engineering or related field or equivalent related experience and a minimum of 8 years progressive experience in quality engineering in the medical device industry to include quality system experience, quality audits (layered process, document, etc), statistical problem solving, statistical sampling technique, SQC, SPC and higher-level statistical problem solving (DOE, t Test, f Test, etc.).
• Experience in materials science, material specification and tolerancing and raw material processing technique.  
• Experience with manufacturing processes in a high-volume, tight tolerance precision manufacturing environment. 
• Management and supervisory experience required. 
• ISO 13485 quality system or equivalent experience.