Quality Assurance Professional

Quality Assurance professional with over 20 years of experience in highly regulated manufacturing environments (disposable medical devices) from start up to fully operational business settings. Knowledgeable and skilled in the implementation and operation of Quality Systems and Quality Standards based working environments. Fully capable to work within, develop, or lead a company’s Quality Assurance, Quality Engineering and/or Quality Control Systems elements or audit such systems for compliance. Proficient in building and assisting with the development and operation of a quality organization in support of manufacturing, product development or laboratory venues. I am currently available to perform the following type of work: • Consult on the development and implementation of standard based Quality Systems (ISO 9000, ISO 13485) • Compliance auditing of a company’s Quality System elements (ISO 9000, ISO 13485) or their suppliers • Perform Quality Control and/or Quality Engineering testing as required by a company’s internal procedures or protocols • Development and validation of product sterilization processes and associated product testing using Steam, EtO Gas or radiation (gamma and E-beam) • Prepare testing protocols and reports for a variety of manufacturing and associated QC processes • Prepare Quality System operating procedures and train personnel accordingly • Provide guidance for regulatory based audits or inspections

Quality Engineer

Baraboo, WI