Daniel Belka Email & Phone Number

St. Paul, Mn

Quality Specialist with responsibility for Infection Prevention Division Hardware products .

Lead the Quality Assurance effort for two new Class II medical device product introductions. Authored and recorded High level Quality assurance plans, test procedures and test results in the product Design History Files including one that was audited without findings by the FDA. Led cross functional initiatives including engineering, marketing , and regulatory affairs groups to establish testable product requirements. Derived product requirements from China Medical Product standards GB/T 14710 and ASTM 4169 shipping standards. Led ISO 14971 compliant risk management analysis for two new products. Prepared design verification and validation plans to verify all product requirements and validate that Carestream's imagers met user needs and intended uses. Provided high level QA plans, verification plans, validation plans, and test results in support of a class II moderate level of concern 510(k) submission. Deployed automated test methods based on Compuware Test Partner and internally developed test tools. Prepared test plans, test procedures, and reported results in DOORs requirements management system. Led an effort to demonstrate statistical equivalence of critical product requirements to a legally marketed predicate device.Developed vendor process validation plans including quality specifications and sampling plans for laser imager molded parts.Created standard operating procedures to establish standards for critical to function requirements for Carestream's Laser Imagers.Wrote end user quality control manuals that insure compliance with ACR, NEMA, EUREF, AFSAAPS and RANZCR requirements for Mammography quality control.