Senior Quality Engineer for Operations Quality

4 weeks ago


Tempe, Arizona, United States LanceSoft Full time

Job Description:

At LanceSoft, we are seeking a highly skilled Senior Quality Engineer for Operations Quality to join our team. As a key member of our quality team, you will be responsible for ensuring the quality and compliance of process development and manufacturing of implantable electronic products at our Tempe Campus.

Responsibilities:

  • Ensure internal quality processes, procedures, and systems are compliant to all governing standards.
  • Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
  • Use knowledge of statistics on acceptance criteria, DOE, and comparison testing to support manufacturing engineers in the development of compliant test plans and reports.
  • Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
  • Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting, and other performance measures.
  • Support CAPA investigations, improvements, and effectiveness verification testing.
  • Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross-functional teams while simultaneously performing the role of Quality Engineer.

Requirements:

  • Strong background in IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
  • Strong understanding of regulatory requirements (i.e., ISO, FDA-GMP, etc.).
  • Strong understanding of medical device manufacturing processes and products.
  • Bachelor's degree in Engineering or technical discipline.
  • 4+ years of engineering experience in a medical device manufacturing environment.

A Day in the Life:

As a Senior Quality Engineer for Operations Quality, you will have the opportunity to work on complex quality-related projects and collaborate with cross-functional teams to ensure the quality and compliance of our products. You will be responsible for developing and implementing quality standards and protocols, conducting quality assurance tests, and performing statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

What We Offer:

LanceSoft offers a dynamic and challenging work environment, competitive compensation and benefits package, and opportunities for professional growth and development.



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