Senior Quality Engineer, Medical Device  (Job ID 172 SQE)
Ann Arbor, MI

The Senior Engineer, Quality for a leading medical device company will responsible for investigating, planning, and implementing the more complex improvements in current products and quality processes that directly affect safety. You must be able to manage innovative engineering projects to completion and become embedded with leading major strategic projects requiring engineering team effort or a multi-discipline team effort consisting of both inside and/or outside resources. Part of your duties will include budget responsibility and you will manage engineering related duties or projects to lower level and/or outside engineers, designers, and technicians.You will monitor and control programs, possess knowledge of appropriate proprietary technologies, and be considered the technical expert in engineering inside and outside the company. 

Primary Responsibilities:

• Ensuring compliance to the company’s quality policy
• Respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.
• Maintain and follow proper ISO procedures and GMP requirements
• Provide leaderhsip and technical expertise and leadership required to plan and implement projects to develop, install, and qualify new products
• Provide engineering expertise in the design, fabrication, development, installation, validation and qualification of equipment and the product line
• Monitor and control programs, identify issues and ensure they are resolved
• Ensure proper documentation is prepared or corrected to reflect any changes implemented
• Research and implement cost reduction projects, lines, extensions, and/or products
• Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required
• Assign, delegate and assist in the completion of engineering tasks or projects to lower lever engineers. Serve as mentor to entry level engineers
• Participate in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement

Education Requirements:

• Bachelor’s degree in Electrical Engineering
• Master’s degree or PhD in an appropriate engineering discipline is strongly preferred

Position Requirements:

• At least 10 years increasing responsibility and experience within a manufacturing environment, designing, specifying, fabricating, assembling, validating and debugging machinery and product and manufacturing processes
• Must have current working knowledge and understanding of technologies, patents, and competition in designated areas of engineering expertise, and a proven ability to successfully manage major strategic engineering projects
• Prior engineering related supervisory/project leadership experience needed
• Knowledge in finance to work with and understand general cost accounting principles
• Ability to create and work from engineering drawings and/or specs of particular engineering discipline
• Thorough knowledge of statistical techniques/methods, engineering drafting and personal computers
• Excellent communicating skills both verbal and written
• Thorough knowledge of electronic/chemical equipment and tools used in laboratory testing and inspection systems
• Thorough knowledge of electromechanical systems, DC servomotor/position control systems, and electrical circuits as appropriate
• Knowledge of GMP/FDA regulations

Click here to apply online   

For additional information, please visit our website at www.LegacyMedSearch.com