Markus Petersen

As a Compliance / Quality Specialist at BIOTRONIK, Inc., I managed quality project dashboards and reports integrating a number of sales, manufacturing and financial data systems. A large portion of my time was working on a wide range of quality projects and processes from audits of medical devices to preparing FDA required reports and establishing OEM Supplier Evaluation processes.

At Genentech, I worked as a full time contractor specializing in review and writing of technical documentation, corrective action / preventive actions (CAPA) and risk management plans. I was part of a project team handling implementation the transference of complex drug manufacturing operation in the U.S. / Switzerland to a joint venture partner in Korea.

At Berkeley Advanced Biomaterials, I was responsible for CAPAs, from initiation to effectiveness verification, and managed QC processes and streamlined existing systems to maximize process efficiency. Collaborated with external testing partners in result analysis of various biological testing equipment. Achieved no findings for one FDA and two ISO inspections during my employment at BAB.