Quality Systems Specialist

Job Description

Job Description

The Quality Systems Specialist role is responsible for supporting all areas of the pre-and post-market quality system activities; ensuring that the Quality System complies with FDA, ISO and customer requirements.Role and Responsibilities:Employ quality assurance methodologies in support of quality, engineering, manufacturing and regulatory functionsResponsible for the collection and management of environmental monitoring samples Support Quality Management System processes such as, but not limited to, control of nonconforming product reports, product holds, deviations, etc. Conduct internal and supplier auditsAssist in Risk Management activities, FMEAs and ensure compliance to standards and regulationsInvestigation and management of customer complaintsParticipate in the failure investigation of product complaint and CAPA activitiesLead root cause activities for CAPAs and other systems as neededTrend quality system metric dataAssist in preparation for external inspections/auditsReview for completeness and adequacy of the Design History FilesAssist in Quality Control functionsOther tasks as assigned.Qualifications:Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field) and minimum of 1 year of experience Ability to work in a fast paced, collaborative team environmentAbility to handle multiple projects and coordinate cross functional teamsKnowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Good Manufacturing Practices (GMP) and applicable Quality System StandardsCertified internal/lead auditor is a plusAble to use and demonstrate root cause analysis toolsExcellent verbal and written communication skillsEffective problem-solving skillsAbility to work in a team minded approach to achieve individual and company successFluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project programs