Product Quality Engineering Manager

WHO WE ARE:NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography, and is also the US headquarters for sales, marketing, service and distribution of all Samsung digital radiography and ultrasound systems. Our advanced medical technologies are used worldwide in leading healthcare institutions, helping providers enhance patient care, improve patient satisfaction, and increase workflow efficiency. Samsung is committed to being a leader in the field of healthcare imaging.Samsung is a growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers. In 2015, NeuroLogica became the US headquarters for all of Samsung Health and Medical Equipment. The full range of Samsung imaging solutions includes Ultrasound, Digital Radiography, and mobile Computed Tomography (mCT). Samsung aims to become a global leader in the medical imaging space and is investing heavily in developing innovative, advanced imaging technologies that will improve the quality of people's lives.Samsung keeps a constant eye on the always-evolving, ever-changing imaging industry. By continually enhancing current product lines and seeking to develop new technologies, Samsung is at the forefront of the imaging frontier.ROLE DESCRIPTION:The Product Quality Engineering Manager leads a team of engineers and technicians responsible for daily quality control operations & continuous improvement of product quality for Computed Tomography imaging systems.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assignedDefine, optimize, implement & maintain testing strategy for sub-assemblies and system-level testing for finished Computed Tomography productsDefine, optimize & maintain documentation for incoming inspection, assembly procedures, test procedures, capital equipment specifications and production tooling specificationsPlan & execute system and software verification and validation for design changes, new product releases and continuous improvementManage daily product quality operations such as incoming inspection, in-process testing, review and verification of product labeling, and final product acceptance & release for shipmentGenerate appropriate metrics to quantify product quality & drive continuous improvementInvestigate and document non-conformances, deviations, and product defects both in production & the install base. Lead root cause analysis and implementation of corrective actionsMaintain analysis of failing components, subassemblies and other issues in production & the install base. Drive actions to deliver measurable product quality improvements across the Computed Tomography product portfolioCoordinate external safety testing for changes at system level, critical components and end of life partsProvide subject matter expertise to ensure deviations, CAPAs, product validation, equipment calibration, facility controls and change management meet regulatory requirements and industry practicesSupport quality department initiatives to meet corporate goals and objectives and ensure compliance with medical device regulationsSupport preparation of field action documentation and executing the field action processSupport procurement in monitoring component obsolescence; identify alternate/substitute parts to maintain supply continuity. Plan & execute verification and validation necessary to support part obsolescence change managementAttend/complete all required training and follow all company policies regarding travel, expenses, meetings, and mealsPerform other duties and functions as needed by ManagementRequired Skills & AttributesB.S. in Engineering required. Mechanical, Electrical or Mechatronics Engineering degree preferred7+ years of experience in manufacturing or service of electro-mechanical or other complex systemsProven problem solver & clear thinker. Skilled in leading teams and motivating staff to deliver exceptional results within a predictable timelineCommunicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors and customersFlexible: able to follow directives and accomplish tasks outside of normal duties In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hireProficiency with MS Office Suite (Excel, Word, PowerPoint, Outlook, etc.)Beneficial Skills & AttributesStrong technical understanding of imaging system performance testing and regulatory complianceKnowledge of Medical Device Regulatory & Quality Standards for the following:ISO 13485 / MDSAP / EU MDRIEC 60601-1 standards for Medical Devices safety, EMC and usability requirementsISO 14971 Risk Management requirementPhysical RequirementsOccasionally lift and /or move up to 25 poundsFrequently required to sit; use hands to finger, handle, or feel; reach with hands; and talk or hearMust be able to sit for long periods of time The noise level in the work environment is usually mildSpecific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focusInteraction with x-ray devices; for this reason strict safety and tracking programs are in place, requiring the utilization of dose monitoring equipment either full time or as necessitated by situationCOMPETENCIESHigh attention to detailUnderstanding of terminology and ability to share and communicate effectively within the groupAbility to organize and prioritize tasks resulting in consistent productivityAbility to function within and support a team environment and build strong working relationshipsDependable and punctualAbility to meet accuracy and productivity goalsGood problem-solving skills, ability to evaluate situation and prioritize factors in decision makingSelf-motivated, utilize available resources for self-improvement and developmentFlexible: able to follow directives and accomplish tasks outside of normal duties About NeuroLogicaLocated North of Boston in Danvers, MA, NeuroLogica Corporation, a subsidiary of Samsung Electronics, develops, manufactures and markets innovative medical imaging equipment for healthcare facilities and private practices worldwide. As a fast-moving, entrepreneurial company, NeuroLogica is a rapidly growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers. We welcome you to learn more at: https://www.neurologica.com .We offer a comprehensive benefit package which includes; 4 Different Blue Cross/Blue Shield Medical Plans to meet your needs Dental coverage through BlueCross/Blue Shield Dental Vision coverage by Blue Cross/Blue Shield Company paid Short-term and Long-term Disability coverage $1 for $1 401k match up to 5% managed by Fidelity Other benefit options such as company paid employee life insurance, a wellness program, tuition reimbursement and many more!NeuroLogica welcomes diversity and is an AA/EEO Employer – Minorities/Women/Veterans/Disabled and other protected categories are always encouraged to apply.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. 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