• Share :

Top 3 required technical skills:

  • Project Management, Problem Solving, and Organization this person will be responsible for multiple different tasks at the same time and will be required to manage them appropriately to ensure project timelines are met.
  • We also typically run into multiple issues, whether that's inspection method issues or supplier issues so problem solving skills will be required.

Nice to have skills:

  • Experience in receiving inspection
  • test method validation
  • statistical capability
  • working with suppliers is a plus!

  • Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Key Responsibilities:

  • Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
  • Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
  • Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
  • Develop, update, and maintain technical content of risk management files
  • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
  • Other incidental duties assigned by Leadership

Education/Experience:

  • Bachelor's degree in engineering required.
  • 2-4 years experience required.

Read the full job description and apply online on the recuiter's web-site

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