Quality Assurance Specialist - Product Complaint
Integrated Resources - marlborough, MA
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This quality engineer is focused on Post Market Quality: o Assess complaints and assign the applicable complaint failure mode and determine if escalation is required if the event is related to a Potential Adverse Event (PAE). o Escalate events to the Clinical Specialists and/or PMS Manager when there is any Potential Adverse Event described. o Testing of returned units from reported complaints. o Ensure complaint investigation procedures are best in class and aligned with the requirements. o Close complaints in a timely manner. o Ensure KPIs are met in accordance with the established goals. o Review and approve complaint investigations in the QMS, as required. o Provide input to the organization regarding the information gathered from complaint investigations. o Support preparation of budget forecasts and ensure compliance with the approved budget. o Implement tools to ensure laboratory expenses are met in accordance with the approved budget and forecast. o Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance's requirements. o Support Product Transfers. o Participate, support and/or lead PMS projects o Support and promote the implementation of EHS programs to ensure staff safety and environmental health. o Communicate with OEMs and CMs, as needed and send the applicable complaint information to the corresponding vendor. o Coordinate services with suppliers and availability of the required supplies in house. (as applicable). o Coordinate and ensure that required payments to vendors are performed on time. o Make decisions following a risk-based approach, implement tools as FMEA, Fault Tree Analysis (FTA) and risk evaluation. o Support other facilities and OEMs/CMs, as required. o Ensure equipment is properly calibrated and controlled with the QMS. Ensure the Preventive Maintenance program is implemented as required. o Execute investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time, in compliance with procedures and regulations. Qualifications o Drive for Results o Planning o Organizational Agility o Listening o Decision making o Problem Solving o Communication Education o University Bachelor's degree in engineering, or related career. Specialized Knowledge (Desirable) o FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14947, EU MDD/MDR and any related ISO and AAMI standards. o Equipment qualification. o Laboratory good practices. o Test method and procedure development o Statistics Languages required for the position: o Native English Computer tools and knowledge level required (Desirable) / Herramientas informa ´ticas y nivel de conocimiento requerido: o Microsoft Office, Internet, Minitab, Oracle, Agile and H1.
Created: 2024-10-16