Sr QA Development Manager

Biosite is the leading provider of rapid medical diagnostics that improve the quality of patient care and simplify the practice of diagnosing critical diseases and health conditions. Our existing product portfolio and product roadmap respond to the challenges faced by hospitals and physician offices by providing cost-effective diagnostic information rapidly - in minutes versus hours, which helps save lives. Biosite?s current products include rapid point-of-care diagnostics in cardiovascular medicine, specifically congestive heart failure and myocardial infarction. Biosite manufactures and markets one of the most widely used toxicology panels, which assesses overdose of a broad spectrum of common prescriptions and illicit drugs. Founded in 1988 as a venture-backed start-up, Biosite has become a biotech success story. The company went public in 1997 with 120 people and has grown to 1,000+ employees worldwide. Our revenues have also continued to grow and are expected to exceed $300M in 2006.

Position Description:

The QA Design Control Manager is responsible for the completion of all Quality Assurance new product deliverables for In Vitro Diagnostics assays. This person will also participate in generating improved Quality Assurance Design Control SOP requirements. For specific products, this person is responsible for writing Design Control Quality Plans and acquiring documentation in support of the plan. Additional responsibilities include the review of design verification and validation data and the review and approval of device master record transfer documents. This individual will be a member of the design teams and provide QA stage gate approvals.

To Apply Visit Biosite

Qualifications:

The position requires a BS in Chemeistry, Biology, Engineering or associated sciences.
The ideal candiidate should have 8 or more years of QA experience in IVD, Medical Devices or related regulated industry. Experience directly with assay development or design transfer is desired.