About Precision NanoSystems Inc. (PNI)
Precision NanoSystems Inc. (“PNI”) is a manufacturer of instruments, kits and reagents in the global nanomedicine market providing tools for drug development and cell-specific delivery to study, diagnose and treat disease. PNI’s NanoAssemblr family of instruments allow scientists to rapidly develop novel nanomedicine drug candidates for pre-clinical testing. PNI’s NanoAssemblr Scale-up platform enables the translation of these drug candidates to clinical testing and eventually to commercial use. PNI’s NanoAssemblr™ Transfection Reagents use nanomedicine technology to deliver genetic materials in primary cells vitro and in vivo, enabling disease researchers to easily study gene function in high-value models of disease. PNI sells its products to leading pharmaceutical and biotechnology companies, and leading academic institutions in over 20 countries worldwide. Please find more information at http://www.precisionnanosystems.com/ .Position SummaryThe Quality Analyst ensure that the quality standards of the company are maintained within PNI procedures, policies, purchased components, manufactured products and customer satisfaction. The Quality Analyst will support the implementation of processes and procedures including the Quality Management System as well as support other functions of the Quality Department as needed. This position is responsible for assisting in monitoring the processes and procedures of the Quality Management System. Initiating problem solving, root cause analysis, remediation, correction and prevention as appropriate. This includes completion of all supporting.Job ResponsibilitiesActively participate in corrective and preventative action processes by providing technical expertise in root cause analysis and action plan development to prevent and eliminate issuesPerform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirementsSupport new product launches, ensuring compliance with established standardsDrive and initiate continuous improvement using feedback from customer issues to improve customer satisfactionSupport PNI’s supplier quality management process to establish quality requirements from external suppliersPerform quality systems and compliance audits, including supplier audit as requiredSupport in maintaining and developing PNI’s Quality Management System (QMS) required for the manufacture and distribution of productsDetermine quality improvement parameters by identifying statistical methods relevant to manufacturing processesEffectively interact the across organization to maintain product quality and customer satisfactionQualifications And Experience
Degree in life-science, engineering or business-related field is required3-5 years of quality assurance experience in a biotech industry, medical device or in a relevant industryExperience in implementing quality systems (such as ISO 9001, ISO 13485 or similar)Ability to assess assigned tasks to identify potential challenges and communicate effectivelyAbility to manage and lead projects in a cross functional environmentProficient in application of QA principles, concepts, industry practices, and standardsThorough understanding of the ISO 9001 standard and other international quality systems regulations to adopt best in class systems and processesSolid experience in implementing Statistical Process ControlAnalytical, detail oriented and excellent grasp of problem-solving skillsAbility to influence individuals and teams to achieve desired goals and objectives and supporting contributors and across organizational levelsExcellent verbal communication, technical writing and interpersonal skillsAbility to effectively manage multiple projects/prioritiesStrong planning and organizational skillsProficient in using Microsoft Office applicationsExperience in using Sharepoint is an assetExperience in Lean Six Sigma is an assetWhen you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.
