Sr QA Engineer

Works on problems of more complex scope where analysis of situations or data requires a review of a variety of factors. Builds productive internal/external working relationships. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in house and/or external specifications and standards (i.e. GLP, GMP, ISO Six Sigma). Involve in review, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Involve in designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. May supervise and administer specific aspects of the quality system. Some examples include Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training. Performs internal audits to ensure systems consistently comply with requirements and are effective. Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs. Leads risk management, validation, sample size, and external standards review and implementation activities. Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs. Coordinates the disposition of nonconforming materials with the Materials Review Board. Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools. Reviews schematics and mechanical drawings. Assumes and performs other duties as assigned. Bachelor's degree and minimum of 5-8 years of related experience; or Master's degree and 2-5 years equivalent industry experience. Medical Device experience preferred. Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems). Must have strong communication, presentation, organization, planning, and the interpersonal skills necessary to work as a team member and act as a liaison with customers. Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel, Power BI, MiniTab/JMP) is preferable.