This position is located in Michigan.

This position is responsible for investigating, planning, and implementing the more complex improvements in and/or additions to current products and manufacturing processes that directly affect safety, quality, and productivity with the end result of producing a better quality product more efficiently. Ensure compliance to company's quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.

• Maintain and follow proper compliance and quality systems requirements.
• Plan and implement specified projects to be completed including organizing and leading members of various sections, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.
• Lead cause-identification and problem-resolution on any type of quality issue that arises.
• Provide engineering expertise in the design, fabrication, development, installation, validation, and qualification of equipment / product which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment.
• Provide assistance for planning and implementation of projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.
• Research and implement cost reduction projects.
• May implement and maintain plant wide calibration system and drawing control/document control system.
• Gathering, tracking, and analyzing production data for meetings, business plan, etc. (yields/output/efficiencies).
• Plan work schedules, expenditures, attend meetings, and prepare monthly reports a required.

Requires a four-year degree in an engineering discipline coupled with at least 4-5 years experience in an engineering environment for designing, specifying, fabricating, assembling, validating, and debugging machinery / product and manufacturing processes. MS in appropriate engineering discipline preferred. Ability to create and work from engineering drawings and/or specs of particular engineering discipline. Good analytical and problem solving skills. Sound knowledge of statistical techniques, engineering drafting and personal computer knowledge, Windows-based software (Outlook, Word and Excel preferred). High level of English communication skills, including strong technical writing and verbal communication skills. Ability to lead project work. Knowledge and utilization of electronic / chemical equipment and tools in laboratory testing, inspection systems, etc. Knowledge of GMP/FDA/ISO(QA)/CMDRs(QA) regulations. Prefer appropriate certifications for particular engineering discipline. 

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