Quality Assurance Manager at Ametek, Inc.

Ametek Paragon Medical Advanced Surgical

Job Description

Paragon Medical, a business of AMETEK, is a trusted partner in medical device manufacturing, offering end-to-end solutions from concept to final production. With expertise across various applications, we deliver high-precision components and complete products tailored to exceed customer expectations.

Job Summary

The Quality Assurance Manager leads the quality department. Improve safety, quality, delivery, productivity, and cost.  Increase quality team skills and capabilities.  Continuously improve levels of customer and associate satisfaction while improving efficiency. 

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.
• Safe operation of all quality processes.   Identifies improvements needed and leads project for implementation. Continually monitors area and solicits feedback from associates. Enforce all safety rules and regulations.   Actively participates in safety, health and wellness initiatives.
• Effectively communicates to all levels of the organization including exempt and non-exempt.  Accomplishes this 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, objectives, policies, procedures and systems.  Communicates quality goals, metrics and standards to the organization
• Identify quality related organization wide training needs and develop programs.  Assist in delivering training.
• 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 qualification and equipment validation.
• 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.
• Performs internal audits.
• Benchmark industry best practices.  Develop and implement programs to promote excellence.
• Ensures compliance with national and international standards and legislation.
• Supervise quality technical staff to ensure technical excellence.  Provides leadership for associate relations through effective communications, coaching, training and development. 
• Executes plan to enhance profitability, productivity and efficiency throughout the quality department.  
• Provides leadership for problem resolution to facilitate fast changes while maintaining working relationships. 

Education and/or Experience

• Bachelor's degree (B. S.) in Mechanical Engineering or related technical field from a four-year college or university 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.