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Job #02783

About our client Our client is a global medical device company with operations in over 60 countries. They have a leadership position in their targeted markets and an established reputation for having the dynamic environment and innovation focus of a small company, with the resources and brand presence of a large company. This is a great opportunity for the right candidate! Position Location Quality Assurance Director Indiana Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead QA and statistical process control in manufacturing and new product development 2) Act (with a hands-on approach) as a team member throughout all phases of projects (FDA and ISO regulated) 3) Establish departmental objectives 4) Report directly to the managers within the QA Department (Quality Engineering, Quality Control, Supplier Quality and the Metrology managers) 5) Plan and conduct the analysis, inspection, design, test and/or integration to ensure quality of the assigned product or component 6) Provide guidance for sampling plans and for the development of instructions for recording, evaluating and reporting quality and reliability data 7) Ensure that Statistical Process Control (SPC) methods for analyzing data are used to evaluate the current process and process changes 8) Provide guidance on gauge development applicable to products and tolerance 9) Communicate significant issues or developments identified during quality activities and provide recommended process improvements to the management 10) Provide guidance and initiate Corrective and Preventive Action (CAPA) plans with root cause analyses 11) Develop quality plans (as needed) 12) Provide technical and administrative guidance to workers engaged in quality activities 13) Maintain a working knowledge of government and industry quality codes and standards 14) Provide leadership for product quality-related matters 15) Ensure that standards and methods for inspection, testing and evaluation are met 16) Provide leadership and personnel for lean initiatives related to quality of product Requirements 1) BS or higher 2) Minimum 10 years of experience in medical device product quality assurance 3) American Society for Quality (ASQ) Green and/or Black Belt certifications or equivalent 4) Experience in Lean Manufacturing and Six Sigma 5) Knowledge of FDA and ISO regulations in relation to medical devices 6) Working knowledge of statistical sampling, blueprint reading, gauging concepts, geometrical dimensions and tolerance 7) Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents 8) Ability to respond to common inquiries/complaints from customers, regulatory agencies or members of the business community 9) Ability to effectively present information to the team members with an emphasis on training 10) Ability to comprehend and apply principles of advanced calculus, modern algebra and advanced statistical theory 11) Ability to work with concepts such as limits, rings, quadratic and differential equations as well as proofs of theorems 12) Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis and statistical process control 13) Ability to define problems, collect data, establish facts and draw valid conclusions 14) Ability to interpret an extensive variety of technical instructions in mathematical or diagrammatic form as well as deal with several abstract and concrete variables 15) Understanding and implementation experience in the following tools 5S, Kaizen, Kanban, Value Stream management, poka-yokes, SMED, etc.