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Quality Engineer

  • Location: Newark, New Castle County, Delaware, 19702
  • Job Type:Contract to Hire

Posted 16 days ago

Position: Quality Engineer
Location: Newark, Delaware, 19702
Term: 11 months
Day-to-Day Responsibilities:
  • Act in a supporting role to technical experts, and will conduct tasks such as reviewing qualification documents for accuracy and compliance, completing documentation required to validate processes and equipment while remaining compliant to the company’s Healthineers Quality Management System.
  • Navigating SAP and the company’ Documentum suite, etc.
  • The role may support the company’s’ auditors for audit responsibilities such as Supplier Quality Management System audits and Supplier Manufacturing Readiness Audits. Travel to/from suppliers and the Glasgow, DE site throughout the project may be required, with the opportunity to work from home when travel is not required.
  • The role will have varying time commitment responsibilities, from zero to 40 hours per week, depending on project status.
  • The position will augment activities such as those described above for the Glasgow Supplier Operations team.
Is this a good fit? (Requirements):
  • Bachelor of Science, at minimum, in relevant field, such as mechanical engineering or biomedical science.
  • Minimum 4 years’ experience working in FDA-regulated medical device/ pharmaceutical/ healthcare manufacturing environment and expertise in navigating the associated Quality Management System.
  • Demonstrated ability to navigate and execute tasks within SAP.
  • Strong familiarity with engineering documentation such as engineering specifications, engineering drawings, validation reports including (IQ, OQ, PQC) required for FDA-regulated manufacturing.
  • Strong communication skills.
  • Experience with CAPA, IR, and SCAR within healthcare product manufacturing environment.
  • Experience conducting supplier audits.
  • Demonstrated high level critical thinking and problem solving abilities with experience containing problems, conducting and documenting root cause, and identifying and executing solutions.
  • Demonstrated ability to attain results while balancing technical solutions with business needs.
  • Strong interpersonal skills with demonstrated ability to work across organizational boundaries, build networks, and collaborate in a team environment.
  • Ability to act independently while managing complex and ambiguous tasks with minimal direction.
Even better if you have:
  • Expertise in navigating Siemens Healthineers’ Quality Management system or similar Quality Management System such as pharmaceutical manufacturing, medical device manufacturing, etc.
  • Experience working in FDA regulated environment.
  • Experience working with products used in diagnostic or analytical laboratories.
  • Experience managing suppliers.
  • Strong working knowledge of statistics and design for manufacturing.
  • Experience with plastics, injection molding, and materials engineering, including robust understanding of injection molding process validations (IQ, OQ, PQC) required for FDA-regulated manufacturing.


Candidates will be responsible for following the client's COVID-19 protocols. Please refer to your MATRIX representative for specifics.

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