QA Engineer II

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOffice, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionHow will you make an impact?The Quality Assurance (QA) Engineer with demonstrated experience driving and sustaining improvement to quality systems, and ensuring that products manufactured to meet internal, customer, and regulatory requirements. The ideal candidate will strengthen our quality system, promote alignment to Quality Assurance policies and requirements, and drive the execution of quality goals and objectives.A Day in the Life:Expert at QMS Deployment and Systemic Problem Solving, ensuring compliance with ISO9001, ISO13485, FDA 21CFR Part 820 in all systems and proceduresManage the internal audit program and support external audit readinessTrending and reporting of dataFacilitate CAPA and investigationsManage QMS deviations promptly and ensure reporting of critical issuesSupport New Product Introductions (NPI) by interacting with various teams to ensure product and process complianceSupport customer complaints resolution and field actionsDrive continuous improvement across the OrganizationMaintain a culture of high employee engagement, teamwork and flexibilityKeys to Success:EducationMinimum Education Required: Bachelor's degree in Scientific/ Technical field.Experience1-2 years of relevant Quality experience in an ISO 9001, ISO 13485 environment requiredKnowledge, Skills, AbilitiesAuditing experience, ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferredKnowledge of the US FDA Quality System Regulations and ISO 13485Knowledge and understanding of Design Control and Risk ManagementSuccessful with influencing and getting resultsStrong analytical skills and attention to detailSelf-motivated with the ability to work as part of a team and/or independentlyExcellent verbal and written skills to successfully communicate to a variety of internal and external audiences, while counseling, discussing and formally presenting views and/or technical criteriaWe offer competitive salary, an annual incentive bonus plan, 401K with company matching up to 6%, and a range of other employee benefits!