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Quality Engineer

Company: System One
Location: Elkton
Posted on: June 25, 2022

Job Description:

Title: Sr. Quality Engineer I Location: Elkton, MD Schedule: M-F 8-5pm Type: Direct/Permanent Compensation: -Midpoint 102,500 -*please note this is the midpoint and there is flexibility depending on experience* Start date: Immediate This position is responsible for providing quality engineering experience and support to operations and product development engineering to investigate, plan, and implementing product quality improvements in and/or additions to current products and manufacturing processes that directly affect safety, quality, regulatory compliance, and/or productivity Responsibilities:

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Provide quality engineering expertise and leadership required to plan and implement specified projects to be completed including organizing and leading projects of various departments, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.
  • Lead cause-identification and problem-resolution for various types of quality, production, or service-related issues.
  • Monitor and control quality processes, identify issues and ensure they are resolved.
  • Provide guidance in the design, fabrication, development, installation, validation, and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training.
  • Plan and implementation of quality related projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.
  • Plan work schedules, expenditures, attend meetings, and prepare monthly reports as required.
  • Maintain and support ESD program as required by site. Responsibilities may include updating ESD documentation and monitoring ongoing practices.
  • Assign, delegate, and assist in the completion of engineering tasks or projects to other engineers in the department. Requirements:
    • Requires a four-year college degree in an engineering, scientific, or technical discipline with a minimum of six years of experience in a Quality Engineering or Process Engineering role in a regulated environment or a master's degree with a minimum of five years of experience. In lieu of a four-year degree, a high school diploma or equivalent, and eleven years of quality engineering experience in a regulated manufacturing environment.
    • Intermediate computer software skills, i.e. Microsoft Office. Industry-recognized certification (e.g. CQE, CQA, PE) preferred.
    • The position exists in office and manufacturing environments within a manufacturing facility. May require gowning procedures for controlled environment. May work in lab environment with chemicals, electronic equipment, bovine and/or human blood, and/or biohazardous materials that require the use of personal protective equipment. May require the use of eye protection, hand protection, and, depending on noise level, may require hearing protection. Requires sitting for long periods of time with occasional stooping, bending, reaching, grasping, etc.
    • May require occasional lifting, carrying, pushing, pulling, of objects up to, but not limited to, 40 lbs. Frequent repetitive motion tasks performed.
    • Requires travel up to 10%.This position may be eligible to work remotely 20% of the time. This may change based on job responsibilities, project/business needs and/or Associate job performance.

Keywords: System One, Wilmington , Quality Engineer, Engineering , Elkton, Delaware

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