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Quality Manager, IVD Systems

4 months ago

Laguna Hills, United States Prelude Corporation Full time
Job DescriptionJob DescriptionDescription:We are seeking a highly motivated and skilled Quality Manager to help develop, maintain and operate a Quality Management System at PreludeDx that meets 21 CFR 820 and ISO 13485 requirements to effectively provide for the development, marketing, support, and use of company IVD products. The ideal candidate will have demonstrable experience in the implementation of quality processes for in vitro diagnostics products, both on the development and on-market sides.
Essential Responsibilities
  • Support development and implementation the Quality Management System (QMS).
  • Support personnel training in quality processes.
  • Generally, manage the application of the QMS.
  • Manage Design Controls processes in product development projects.
  • Interact with and support product development personnel, e.g. in the documentation and other quality aspects of product development projects.
  • Manage the quality assurance processes in manufacturing operations.
  • Interact with and support manufacturing personnel, e.g. in the development of quality assurance and quality control processes and the documentation of QC results.
  • Interact with and support clinical lab personnel, e.g. in the documentation of quality issues.
  • Conduct (or supervise) internal quality audits in the above-mentioned sectors of the company to ensure compliance with government and regulatory bodies including CLIA, CAP, NYSDH, and local.
Requirements:
  • 6 to 8 years of relevant Quality Assurance experience in the biotechnology industry, especially IVD.
  • Experience with IVD and/or LDT product development.
  • Experience in regulated environments such as FDA and CAP/CLIA operations.
  • Hands-on lab experience (molecular biology, anatomopathology) a great plus.
  • Strategic thinking, leadership skills, assertiveness, strong technical background, and project management skills as evidenced by past performance on product development projects.
  • Excellent interpersonal and verbal communication skills.
  • Superior written communication skills as evidenced by past demonstrated ability to understand and clearly express complex data sets and analyses in technical documents.
EDUCATION
· BS/MS in a Life Sciences discipline or equivalent· Quality Certification(s) a plus, e.g. CQA, CMDA, ISO auditor, etc.