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Job #02784

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 Manager New Jersey 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 the projects (FDA and ISO regulated) 3) Develop and initiate standards and methods for inspection, testing and evaluation 4) Plan and conduct the analysis, inspection, design, test and/or integration to ensure the quality of assigned product or component 5) Devise sampling procedures and designs 6) Develop forms and instructions for recording, evaluating and reporting quality and reliability data 7) Apply Statistical Process Control (SPC) methods for analyzing data to evaluate the current process and process changes 8) Document data obtained during all quality activities consistent with company policies and procedures 9) Develop gauging applicable to products and tolerance 10) Initiate corrective and preventative action plans with root-cause analyses 11) Communicate significant issues or developments identified during quality activities and provide recommended process improvements to the management 12) Develop quality plans (as needed) 13) Maintain a working knowledge of government and industry quality codes and standards 14) Direct technical and administrative workers engaged in quality activities 15) Maintain a working knowledge of statistical sampling, blueprint reading, gauging concepts, geometrical dimensions and tolerance Requirements 1) Associate degree (4 year) in Engineering or equivalent combination of education and experience in a manufacturing environment 2) Knowledge of FDA and ISO regulations in relation to medical devices 3) Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents 4) Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community 5) Ability to effectively present information to team members with an emphasis on training 6) Ability to comprehend and apply principles of advanced calculus, modern algebra as well as advanced statistical theory 7) Ability to work with concepts such as limits, rings, quadratic and differential equations as well as proofs of theorems 8) 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 9) Ability to define problems, collect data, establish facts and draw valid conclusions 10) Ability to interpret a variety of technical instructions in mathematical or diagrammatic form and deal with several abstract and concrete variables