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Sr. Quality Specialist

Disability Solutions

Miami, FL
21 days ago
$111,100 - $152,800

Job Description

Join Cepheid as a Senior Quality Specialist and influence the development of groundbreaking diagnostic solutions. You'll be integral to ensuring quality compliance and product stability, impacting patient outcomes globally.

Key Responsibilities

  • Support quality systems activities related to assay development
  • Participate as Quality representative on product development teams
  • Fulfill quality planning, stability, and risk management deliverables
  • Ensure documentation completion prior to new product launch
  • Provide guidance on product shelf-life/stability program
  • Conduct post market investigations and assess design changes

Required Qualifications

  • B.S. degree with 5+ years of related experience or M.S. degree with 3+ years of related experience in Chemistry, Biology, or related field
  • Related work experience in Quality focused on assay development in medical device or IVD industry
  • Knowledge of FDA QSR, EU IVDR, ISO 13485 and ISO 14971
  • Experience in implementing design control and risk management activities
  • Technical data analysis and risk-based recommendations
  • Proficiency in Microsoft Word, Excel, Visio, PowerPoint, and Minitab

Preferred Qualifications

  • Quality Systems/Quality Engineering background in molecular biology or molecular diagnostic products utilizing PCR

Benefits & Perks

Paid time offMedical/dental/vision insurance401(k) planBonus/incentive pay