Join Cepheid as a Senior Quality Specialist where you'll support quality systems in assay development, ensuring compliance with FDA and ISO regulations. Make a measurable global impact while enjoying career growth opportunities.
Key Responsibilities
Participate as Quality representative on product development teams
Fulfill quality planning, stability, and risk management deliverables
Ensure documentation is completed prior to new product launch
Provide guidance on product shelf-life/stability program
Conduct post-market investigations and 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 physical or biological science field
Experience in Quality with a focus on assay development in a medical device or IVD industry
Knowledge of FDA QSR, EU IVDR, and global regulations ISO 13485 and ISO 14971
Experience in implementing design control and risk management activities
Proficiency in Microsoft Word, Excel, Visio, PowerPoint, and Minitab
Preferred Qualifications
Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing PCR
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)Bonus/incentive pay