Director of Quality Assurance

RESPONSIBILITIES: - Lead quality assurance and statistical process control in manufacturing and new product development with hands-on approach as a team member throughout all phases of projects, FDA and ISO regulated by performing the following duties. - Establish departmental objectives. - Direct reports would be the managers within the quality assurance department, Quality Engineering, Quality Control, Supplier Quality, and the Metrology Managers. - Ensure standards and methods for inspection, testing, and evaluation. - Plan and conduct the analysis, inspection, design, test, and/or integration to assure the quality of the assigned product or component. - Provide guidance for sampling plans and for the development of instructions for recording, evaluating, and reporting quality and reliability data. - Ensure that statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes. - Provide guidance for gage development applicable to products and tolerance. - Provide guidance and initiates corrective and preventive action (CAPA) plans with root cause analyses. - Communicate significant issues or developments identified during quality activities and provide recommended process improvements to management.- Develop quality plans as needed.- Provide technical and administrative workers engaged in quality activities. - Maintain a working knowledge of government and industry quality codes and standards. - Must have a working knowledge of statistical sampling, blueprint reading, gauging concepts, and geometrical dimensions and tolerance. - Provide leadership product quality related matters. - Provide leadership and personnel for lean initiatives related to quality of product. REQUIREMENTS: - Lean, six sigma experience required, must have American Society for Quality (ASQ) green and/or black belt certifications or equivalent.- Bachelors Degree (BS) or higher and 10 years plus experience in medical product quality assurance.- Knowledge of FDA and ISO regulations as they relate to medical devices.- Understanding and implementation experience in the following tools is required: 5S, kaizen, kanban, value stream management, poka-yokes, SMED, etc. - Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.- Ability to effectively present information to Team Members with an emphasis on training. - Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory.- Ability to work with concepts such as limits, rings, quadratic and differential equations, and proofs of theorems.- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis and statistical process control.- Ability to define problems, collect data, establish facts, and draw valid conclusions.- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.7 For a complete list of our open positions, please visit our website at www.jobsforsuccess.com. MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Midwest, IN JOB CATEGORY: Quality Assurance/Safety TYPE: Full Time, Employee SALARY: 110,000.00 - 120,000.00 USD /yearFull Relocation Available JOB REFCODE: #1756JBW COMPANY: Management Recruiters of Chicago-Far West CONTACT NAME: Josh Weber PHONE: No Calls Please! EMAIL: Apply by Email