Join Cepheid as a Senior Quality Specialist where you will lead quality systems activities in assay development and ensure compliance with FDA and ISO regulations. This role offers the chance to make a significant impact on healthcare diagnostics while fostering your career growth in a dynamic environment.
Key Responsibilities
Participate as Quality representative on product development teams
Fulfill quality planning, stability, and risk management deliverables
Ensure required documentation is completed prior to new product launch
Provide guidance and technical oversight of product shelf-life/stability program
Provide 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 field
Experience in Quality with a focus on assay development in a medical device or IVD industry
Knowledge of FDA QSR, EU IVDR, ISO 13485 and ISO 14971 regulations
Experience in implementing design control and risk management activities
Proficient with 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