Exalta Group
Position Summary:
Technical Quality Specialist is a cross-functional position that meets at the intersection of quality assurance, quality control, engineering, and manufacturing operations. This role will be a bridge between manufacturing and customers in order to deliver conforming product. Candidate must have a strong technical background with direct experience with medical devices as well as a personable temperament.
Essential Duties and Responsibilities: Manage the daily requirements of the customer complaint system, while working directly with the Service department. Including:
Facilitating and assisting in the initiation of customer complaints, including providing RMAs in a timely fashion. Providing timely communication to customers throughout the execution complaint process. Reviewing issued complaints to understand reportability, need for containment, risk to safety and regulatory compliance, defect, root cause, and disposition; utilizing support from Engineering, R&D, Service, Quality Control, and production as necessary. Documenting disposition of product with proper justification, utilizing support from Engineering, R&D and production as necessary. Performing and documenting Risk Assessment for rework dispositions. Facilitating approval and closure of complaint records in a timely fashion. Conducting regularly scheduled complaint meetings to support timely investigation, root cause determination, disposition and resolution. Facilitating and completing customer complaint records within the digital quality management system. Complete and provide customer responses, including but not limited to complaint summaries, and customer NCMRs and SCARs. Any other duties, as assigned, to facilitate and maintain the customer complaint system, in accordance with ISO 13485, 21 CFR 820, EUMDR 2017/745.
Track and trend all data related to customer complaints, to support meeting Quality Requirements (ISO 13485, 21 CFR 820, EUMDR 2017/745), and overall Continuous Improvement. Reporting monthly KPI, PI and SI data as well as timely completion of monthly customer complaints. Support investigations related to CAPA documentation and NCMRs by working cross-functionally to identify root causes. Recommend improvement actions to prevent recurrence and confirm holistically that the risk was mitigated appropriately. Provide timely responses to the Quality Team as appropriate. Assist with training new and existing employees on Intech procedures, work instructions, policies, protocols and documentation as it relates to manufacturing conforming product. Support activities include the Quality Control Laboratory, Manufacturing Associates and any area that directly impacts product quality. Attend required meetings, to exchange pertinent information, in real time, to ensure customer quality requirements are being met, and to proactively address issues, thereby reducing scrap and rework costs. Assist in manufacturing and quality control trouble shooting activities and projects as requested. Support the Supplier Quality Program by leveraging supplier relationships to confirm standards for precision, capability, quality and on-time delivery are met. Perform Return to Vendor Disposition Activities. Facilitate SCAR activities with Quality Team. Attend Supplier Audits, as requested, to drive quality compliance with suppliers and facilitate reduction of errors at incoming inspection. Perform and assist with Internal audits, providing a non-biased approach, while verifying system and process compliance with ISO 13485, 21 CFR 820, EUMDR 2017/745. Other duties as assigned. Knowledge, Skills & Competencies:
5+ years' experience working withing ISO 13485 and 21 CFR Part 820 quality systems preferred. Knowledge of engineering/CAD drawings, precision machining (CNC) production processes, quality control tools including CMM and Vision Systems, sampling methodologies, and Geometric Dimensioning and Tolerance (GD&T). Computer literate in various software applications including Microsoft Office. Experience with Epicor, ETQ, and TrackWise a plus. Ability to identify complex problems and review related information to develop and evaluate options and implement solutions. Capable of handling stressful situations while maintaining a sense of urgency; ability to prioritize work and effectively manage projects. Communicate effectively in multi-discipline, cross cultural environment, throughout different levels of the organization.
Technical Quality Specialist is a cross-functional position that meets at the intersection of quality assurance, quality control, engineering, and manufacturing operations. This role will be a bridge between manufacturing and customers in order to deliver conforming product. Candidate must have a strong technical background with direct experience with medical devices as well as a personable temperament.
Essential Duties and Responsibilities: Manage the daily requirements of the customer complaint system, while working directly with the Service department. Including:
Facilitating and assisting in the initiation of customer complaints, including providing RMAs in a timely fashion. Providing timely communication to customers throughout the execution complaint process. Reviewing issued complaints to understand reportability, need for containment, risk to safety and regulatory compliance, defect, root cause, and disposition; utilizing support from Engineering, R&D, Service, Quality Control, and production as necessary. Documenting disposition of product with proper justification, utilizing support from Engineering, R&D and production as necessary. Performing and documenting Risk Assessment for rework dispositions. Facilitating approval and closure of complaint records in a timely fashion. Conducting regularly scheduled complaint meetings to support timely investigation, root cause determination, disposition and resolution. Facilitating and completing customer complaint records within the digital quality management system. Complete and provide customer responses, including but not limited to complaint summaries, and customer NCMRs and SCARs. Any other duties, as assigned, to facilitate and maintain the customer complaint system, in accordance with ISO 13485, 21 CFR 820, EUMDR 2017/745.
Track and trend all data related to customer complaints, to support meeting Quality Requirements (ISO 13485, 21 CFR 820, EUMDR 2017/745), and overall Continuous Improvement. Reporting monthly KPI, PI and SI data as well as timely completion of monthly customer complaints. Support investigations related to CAPA documentation and NCMRs by working cross-functionally to identify root causes. Recommend improvement actions to prevent recurrence and confirm holistically that the risk was mitigated appropriately. Provide timely responses to the Quality Team as appropriate. Assist with training new and existing employees on Intech procedures, work instructions, policies, protocols and documentation as it relates to manufacturing conforming product. Support activities include the Quality Control Laboratory, Manufacturing Associates and any area that directly impacts product quality. Attend required meetings, to exchange pertinent information, in real time, to ensure customer quality requirements are being met, and to proactively address issues, thereby reducing scrap and rework costs. Assist in manufacturing and quality control trouble shooting activities and projects as requested. Support the Supplier Quality Program by leveraging supplier relationships to confirm standards for precision, capability, quality and on-time delivery are met. Perform Return to Vendor Disposition Activities. Facilitate SCAR activities with Quality Team. Attend Supplier Audits, as requested, to drive quality compliance with suppliers and facilitate reduction of errors at incoming inspection. Perform and assist with Internal audits, providing a non-biased approach, while verifying system and process compliance with ISO 13485, 21 CFR 820, EUMDR 2017/745. Other duties as assigned. Knowledge, Skills & Competencies:
5+ years' experience working withing ISO 13485 and 21 CFR Part 820 quality systems preferred. Knowledge of engineering/CAD drawings, precision machining (CNC) production processes, quality control tools including CMM and Vision Systems, sampling methodologies, and Geometric Dimensioning and Tolerance (GD&T). Computer literate in various software applications including Microsoft Office. Experience with Epicor, ETQ, and TrackWise a plus. Ability to identify complex problems and review related information to develop and evaluate options and implement solutions. Capable of handling stressful situations while maintaining a sense of urgency; ability to prioritize work and effectively manage projects. Communicate effectively in multi-discipline, cross cultural environment, throughout different levels of the organization.