Senior Quality Engineer

Quality Assurance/Regulatory Affairs PositionEnsure products meet specifications and are developed and manufactured with highest product quality and meet all applicable product quality, design and manufacturing process requirements. Provide support in areas of process engineering, product quality assurance to drive continuous process and product improvements.Implementation of quality engineering tools throughout the organization to drive methodical process development. Utilize quality tools such as lean principles, statistics, sampling plans, reliability engineering, software engineering and design assurance techniques.Conduct engineering activities in compliance with FDA Regulations, ISO 13485, ISO 14971, IVDR, and other national and international quality and regulatory requirements and standards.Conduct investigations and provide corrective and preventive actions based on sound engineering analysis and review. Provide effective and practical solutions that will drive continuous and measurable improvements.Participate in Design Control activities, including Risk Management.Coordinate Post-Market Surveillance activities.Author and manage Quality Agreements with mission-critical vendors, establishing rigorous incoming inspection criteria (including verification vs. vendor CoA protocols).Analyze data, interpret results and write protocols and reports required to document results from assigned tasks.Support the product quality activities through the application of engineering tools and disseminating knowledge throughout the organization.Support Internal, External and Supplier Audits.Support Quality Metrics and Management Review activities.Collaborate internal functions including supply chain, operations to define, develop, and implement continuous improvement with suppliers in the areas of quality, delivery, process optimization, and total cost management. Provide technical assistance to suppliers and other resources performing training and qualification/validation testing.Collaborate with Laboratory Operations, Product Development and other departments to ensure quality processes are implemented. Including product design testing, process testing, equipment/software qualification, validation, risk management activitiesCollaborate with the procurement department in supplier optimization efforts. Tasks include the identification of key suppliers based on supplier competencies/qualifications, quality systems and performance/track record.Serve as back-up Person Responsible for Regulatory Compliance (PRRC)Perform other duties as assigned.The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.Person Responsible for Regulatory Compliance - PRRCBack-up PRRCManagement RepresentativeBack-up Management RepresentativeProduct release under the QMSEnsuring the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.Ensuring the reporting obligations referred to in Articles 82 to 86, Regulation 2017/746 are fulfilled. This includes serious incidents and field safety corrective actions, trend reporting, and analysis of vigilance data.In the case of performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risk for the subjects, ensuring the statement referred to in section 4.1 of Annex XIV, Regulation 2017/746 is issued.InternalLaboratory Operations, Product Development, Marketing, Supply Chain ManagementExternalExternal Suppliers, Notified Body, Regulators: FDA, CLIA/CAP, NYSDOHBachelor's Degree or above, preferably with a concentration in Quality, Life Science, Biology, Pharmacy, Biomedical Engineering, Statistics, or related technical disciplineASQ Certified Quality Engineer, Reliability or Software Engineer requiredASQ Certified Quality Auditor or other Lead Auditor certification preferredSix Sigma Black Belt preferredAt least 3 years' expertise in Regulatory Affairs or Quality Management Systems for medical devices (In Vitro Diagnostic, Class II or Class III medical devices preferred)Knowledge of ISO 13485, ISO 14971, IVDR and 21 CFR 820Knowledge of CAP/CLIA Requirements preferredKnowledge of Analytical/Statistical PrinciplesCustomer Focused Quality Process ImprovementKnowledge of Quality System standardsKnowledge of Root Cause Investigation toolsProject Management SkillsTechnical Presentation SkillsCapable of interacting with all levels of management, employees, supplier and clientsFamiliarity with Supplier Quality and Contract Manufacturing ActivitiesExcellent Verbal/written communication skillsAbility to multi-taskComputer Proficiency, such as MS OfficeCritical ThinkingStrong problem-solving skillsQuality Engineering statistical toolsProject managementPresentation skillsEffective interpersonal skillsResult - and customer orientationInitiativeFlexibilityCan do-attitudeEstablished ADA (Americans with Disabilities Act) requirementsSpecific vision abilities include close vision, distance vision, and color visionWork in a Lab Environment as neededMust be able to read and understand scientific and complex directionsApplicants must be currently authorized to work in the United States on a full-time basis without the need for current or future sponsorship<20% TravelOther duties as required.