Job Description


Job Description:

Pay Range: $64.71hr - $69.71hr
  • The Principal Quality Engineer is responsible for developing, implementing, and maintaining quality systems and processes for In Vitro Diagnostics (IVD) products in compliance with applicable regulatory and quality standards.
  • This role partners closely with cross-functional teams to ensure quality is embedded throughout the product lifecycle, from design and development through post-market activities.
    • Responsibilities:
  • Develop, implement, and maintain quality systems in compliance with FDA 21 CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971, and other applicable regulations
  • Conduct hazard analysis and risk assessments throughout the IVD product lifecycle in accordance with ISO 14971.
  • Lead internal and external audits, including preparation, execution, follow-up, and corrective actions.
  • Oversee CAPA processes, non-conformance investigations, and deviations to resolve quality issues.
  • Collaborate with cross-functional product development teams to integrate quality requirements into design controls, verification, and validation activities.
  • Review and approve design control documentation, including design inputs, outputs, verification and validation protocols, reports, and risk management files.
  • Establish and maintain Design History Files (DHF) for IVD products.
  • Assess, qualify, and monitor suppliers during development and throughout the product lifecycle.
  • Establish, monitor, and analyze quality metrics and performance trends to drive continuous improvement.
  • Support regulatory submissions and product approval activities.
  • Support and manage complaint handling and post-market incident activities, including investigations, trending, field actions, and regulatory reporting
  • Maintain knowledge of laboratory regulatory requirements and applicable accrediting body standards.
  • Drive continuous improvement initiatives using audit findings, post-market surveillance data, and industry best practices.
  • Stay current with evolving regulatory requirements and industry standards.
  • Update internal processes, procedures, and training materials as needed.
  • Follow corporate policies and procedures and perform other duties as assigned.
    • Experience:
  • 8+ years of experience in medical device and/or IVD design and development with strong focus on design controls and risk management.
  • Experience working in FDA-regulated environments preferred.
  • Experience supporting IVD products preferred.
    • Skills:
  • Strong verbal and written communication skills.
  • Ability to influence others and drive results.
  • Effective presentation and problem-solving skills.
  • Strong analytical skills with high attention to detail.
  • Team leadership and cross-functional collaboration skills.
  • Proficiency in Microsoft Word, Excel, and PowerPoint.
  • Ability to function effectively in a matrix organization.
  • Strong organizational and project management skills.
    • Knowledge:
  • Quality Management Systems development.
  • Design Controls and Risk Management.
  • Medical device and IVD regulations including IEC 62304, FDA 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA.
    • Qualification And Education:
  • Bachelor’s Degree required.
    • Certification:
  • ASQ Certification preferred.
  • Regulatory Affairs Certification (RAC) preferred.

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