Medical Device Quality Engineer

Elkton, United States

Job title: Senior Quality Engineer             

Job location: Elkton, MD 21921

Benefits: Medical, Dental, Vision (starts on the 1st of the month following start date), 401k 6% matching, 120 days PTO

Education: Requires a four-year college degree in an engineering, scientific, or technical discipline

Required Experience: Risk analysis, risk management, design/development processes for medical devices, hazard analysis, DFMEA/PRMEA useability, root cause analysis  

Preferred Experience: Industry recognized certification (e.g. CQE, CQA, PE) preferred.

Job Description: 

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.

Medical Device Quality Engineer

Job description

Medical Device Quality Engineer

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