Quality Engineer

Job Description About Scientia Vascular:The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.Quality Engineer Role:This position will work in all aspects of the Scientia Vascular Quality System with a primary focus on product quality assurance. They will work closely with all other departments to develop, implement, and monitor quality systems to deliver quality product to customers while maintaining regulatory compliance. This position has the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, and proactively identify and document potential nonconformance issues.Depending on experience, this position will work under general direction and have latitude in determining how to solve problems while maintaining focus on prevention, continuous improvement, and customer satisfaction.Primary Responsibilities:Work closely with cross-functional partners to ensure product design conforms to internal specifications, customer, and regulatory requirements in order to ensure quality productProvide Quality guidance to Manufacturing Engineers, Technicians and Product BuildersProvide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors. Depending on experience, opportunities may exist to mentor or manage a limited number of technicians, interns, or other more junior engineersWork closely with Operations and Quality personnel to monitor Manufacturing processesPartner with Manufacturing Engineering to review and investigate defects, perform root cause analysis, and develop and implement line improvementsReview designs, changes, and plans of specifications and processesDevelop and monitor quality data and metrics related to productionAssist in CAPA, complaint management, and medical device and vigilance reportingAssist in all aspects of supplier managementAssist in internal and external auditsLead and/or support projects to update and revise Quality Systems and Procedures as necessary to meet the current needs of the organization while maintaining compliance to all applicable standardsDesign and qualify inspection test methods and equipment.Act as direct support for Transfer Engineers during process development and process transfer into productionUpdate and assist in the generation of the PFMEA risk documentationOwn and support Nonconformance Report investigations and any related actions for NCRs generated in incoming or production spacesTake action to maintain and improve product qualityCompile and present data for Management ReviewEnsures the company is in a constant state of readiness for FDA, ISO, and customer auditsOther duties as assigned with or without accommodationRequirements:BA/BS degree in a Life Science, Engineering, Physical Science, a related field of study or equivalent work experience and/or professional qualificationsExperience in a highly regulated industryKnowledge and experience with quality systems, quality and manufacturing concepts, regulatory compliance requirements and applied statistical conceptsExperience with medical device R&D, Regulatory Affairs, Manufacturing or Quality. Preferably in or around a manufacturing environmentAbility to make sound decisions under pressure with reasonable foresight as to outcomesGood oral and written communication skillsDemonstrated knowledge of interpretation and application of QSR, MDD, EU MDR, ISO 13485 and other international standardsDemonstrated expertise in interpretation and pragmatic application of Quality standardsStrong leadership ability, coupled with superior interpersonal, communication and influencing skillsProgressive leadership experience, including "hands-on" quality systems developmentKey benefits we provide:Medical, Dental, Vision insuranceGenerous Paid Time Off (PTO) Paid Parental Leave Paid Holidays401k Plan (with a generous employer match) Life Insurance (company paid) Short-Term & Long-Term Disability Insurance (company paid) Subscription to Employee Assistance Program An environment of belonging where everyone can thrive Commitment to Equal Opportunity:The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. xhyhwjd Consistent with our culture, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, sexual orientation, national origin, genetics, disability, age, or veteran status, or any other non-merit based or legally protected grounds. Visit our website and learn more about us at