Join Cepheid as a Senior Quality Specialist, where you'll support quality systems related to assay development, ensuring compliance with FDA and ISO regulations. You will collaborate with cross-functional teams to drive product quality and stability, making a meaningful impact on patient outcomes globally.
Key Responsibilities
Participate as Quality representative on product development teams
Fulfill quality planning, stability, and risk management deliverables
Ensure documentation is completed prior to product launch
Provide guidance on product shelf-life/stability program and execute stability studies
Offer technical expertise for 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 science
Experience in Quality with a focus on assay development in medical device or IVD industry
Knowledge of FDA QSR, EU IVDR, ISO 13485 and ISO 14971 regulations
Experience in 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 or molecular diagnostic products utilizing PCR
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k) planBonus/incentive pay