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