Senior Quality Systems Engineer

Job Title: Sr. Quality Systems EngineerCompany Name: Quanta Dialysis Technologies Inc.Job Location: Beverly, MAJob Description:Responsible for maintaining the Quality Management System for Quanta Dialysis Technology and support with all Quality compliance related activities, including but not limited to, internal audits, regulatory audits, developing processes and procedures and making sure the organization is compliant with the ISO13485, MDSAP, MDR and other regulatory requirements.Specific duties include:Provide Quality Systems support for sustaining and development projects.Support the organization in developing and updating the Quality Management System (QMS).Provide support and leadership in writing Standard Operating Procedures (SOPs) and Work instructions (WIs) use, maintenance, and repair of biomedical equipment. Support Management review meetings by providing Quality data.Generate weekly and other routine reports for Key Process Indicators (KPI) discussion with the Management.Maintain quality system information databases as assigned.Evaluate quality data and prepare periodic reports to monitor trends.Generate, review, and approve Change requests for Quality Assurance.Manage Employee Training matrix and make sure appropriate assignment of training during hiring process.Perform quality assurance (“QA”), including to meet QMS KPI metrics, and by drafting and reviewing change requests, analyzing and correcting product non-conformities, handling bio-material non-conformities, addressing product quality deviations, and by solving and preventing product problems and failures (all involving biological applications due to product human-clinical use).Support with Monthly Corrective Action Board meetings.Provide guidance and direction to the Quality functions at the various manufacturing facilities which will include supporting CAPA, and Change Control.Support External Regulatory Audits.Perform Internal Audit Schedule and execute Internal Audits.Manage Supplier Quality Metrics.Support with Supplier Agreements and selection and approval of suppliers to add them to the Approved Supplier List.Manage Supplier Audit plans and execution of supplier audits for critical suppliers.Process non-conforming material reports.Ensure any targets set for the business relating to QMS KPI’s are monitored and met where appropriate (e.g. NC, CAPA, complaints resolution, self-training etc.).Job Requirements:Requires a Master’s degree in Biomedical Engineering or a related field and three years of experience.Experience must include:Experience with FDA Quality System Regulation and ISO regulatory requirements.Experience with Regulation 21 CFR Part 820, and applicable international quality standards, such as ISO 13485, MDR, ISO 14971. Experience with part/assembly qualification elements (First Article Inspection, Control plan, FMEA’s, Validations).Development and execution of validation strategies including IQ, OQ, PQ.Statistical process control concepts including Gage R&R & Process Capability.Experience with Supplier qualifications & managing Approved Supplier List.Experience with CAPA, Deviations, Non-conformance, and Complaints.Assessing Manufacturing and Design changes against their impact and supporting the implementation of such changes.Hybrid remote work permitted; must live within commuting distance of worksite. Travel required to unanticipated worksites nationwide. Travel encompasses up to 15% of time.