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Job Description
•Drive measurable quality improvements in support of operations
•Manage quality support for operations including device history record and batch release processes
•Assist various functions as a technical liaison for internal or external Quality matters
•Using Quality Engineering principles, perform statistical analysis and trending of Quality data to proactively identify opportunities and implement System improvements
•Perform regular reviews and annual reviews of employees under direct supervision. Provide performance feedback to employees, and coach as needed to foster employee improvement
•Ensure that Quality Operations employees are qualified and trained to perform their respective job functions, as required by ISO 13485:2016 and medical device regulations.
•Seek out and apply best quality assurance methods and practices in support of Quality objectives
•Develop, implement, and review procedures and work instructions to ensure compliance
•Conduct internal or external audits to assure compliance with regulatory and QMS requirements
•Perform review and approval of Technical File, Device History Records (DHRs), and other records
•Develop, review, and approve engineering change orders for compliance purposes.
•Support 3rd-party, regulatory and customer audits of the QMS, as well as requests for records
•Provide resources for the failure analysis of product, processes, and or systems for the proper identification of root causes and corrective and preventive actions
•Oversee the MRB process or assign a process owner to ensure the timely resolution of NCRs
•Manage quality, compliance, and timely closure of complaints through manufacturing investigations
•Supervise Quality Engineers and Quality Complaint Analysts that process complaints for the site
•Oversee, coordinate, and participate in elements of investigations regarding customer complaints, as required by medical device regulations (e.g., 21 CFR 820.198 and Regulation (EU) 2017/745)
•Perform Process Validation (IQ, OQ & PQ) for new product transitioning from engineering to manufacturing and production, including test system qualification.
•Review qualification, verification, and validation studies in support of product and process changes
•Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately
•Requires successful completion of assigned training
•Manage quality support for operations including device history record and batch release processes
•Assist various functions as a technical liaison for internal or external Quality matters
•Using Quality Engineering principles, perform statistical analysis and trending of Quality data to proactively identify opportunities and implement System improvements
•Perform regular reviews and annual reviews of employees under direct supervision. Provide performance feedback to employees, and coach as needed to foster employee improvement
•Ensure that Quality Operations employees are qualified and trained to perform their respective job functions, as required by ISO 13485:2016 and medical device regulations.
•Seek out and apply best quality assurance methods and practices in support of Quality objectives
•Develop, implement, and review procedures and work instructions to ensure compliance
•Conduct internal or external audits to assure compliance with regulatory and QMS requirements
•Perform review and approval of Technical File, Device History Records (DHRs), and other records
•Develop, review, and approve engineering change orders for compliance purposes.
•Support 3rd-party, regulatory and customer audits of the QMS, as well as requests for records
•Provide resources for the failure analysis of product, processes, and or systems for the proper identification of root causes and corrective and preventive actions
•Oversee the MRB process or assign a process owner to ensure the timely resolution of NCRs
•Manage quality, compliance, and timely closure of complaints through manufacturing investigations
•Supervise Quality Engineers and Quality Complaint Analysts that process complaints for the site
•Oversee, coordinate, and participate in elements of investigations regarding customer complaints, as required by medical device regulations (e.g., 21 CFR 820.198 and Regulation (EU) 2017/745)
•Perform Process Validation (IQ, OQ & PQ) for new product transitioning from engineering to manufacturing and production, including test system qualification.
•Review qualification, verification, and validation studies in support of product and process changes
•Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately
•Requires successful completion of assigned training