Director of Quality

Director Of QualityThe Director Of Quality is responsible for overseeing the quality management system and quality operations, to include document control, quality event investigations, customer feedback/complaints, design control, risk management, and quality control, while ensuring compliance with established standard operating procedures, FDA regulations, AATB Standards, ISO standards and other application regulations and industry standards.ResponsibilitiesDefine and promote a quality mindset throughout the organizationDevelop, implement, and maintain procedures and controlled documents according to FDA regulations, AATB Standards, ISO Standards, and other applicable regulationsProvide subject matter expertise to drive improvements and decisions relating to the quality management system while supporting organizational strategic objectivesOversee management of change control, the document change system, design control, record control, and periodic review of controlled documents and perform associated quality approvalsLead training of new processes, process revisions, and corrective actions relating to qualityOversee management and coordination of training requirements/assignmentsManage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, supply inspections, and device/product inspectionsOversee management of deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigationsEnsure adequacy of investigations with respect to root cause analysis and CAPA assessmentConduct quality review and approval for closure of deviations, nonconformances, complaints, CAPAs, and SCARSLead risk management of department and ensure risks/issues are identified, addressed/reported, and where appropriate, escalatedOversee, lead, and manage quality system related meetings including management reviewEstablish, evaluate, report, and provide improvements (where appropriate) for quality metricsProvide quality oversight, support, and approval for new projects and productsCollaborate, review, and approve validation/verification/qualification plans, protocols, execution data, and summary assessmentsOversee and manage use of quality system software(s)Support documentation requests from regulatory affairs department to support regulatory submissions (e.g. PMA supplements, 510(k) submissions)Direct, participate, and/or support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and standard operating proceduresAnalyze data by conducting hypothesis, normal distribution, and process capability analysis testingDevelop and maintain professional working relationships with current and potential customers, consultants, suppliers, and vendorsEstablish and execute continuing education strategy for departmentMaintains company compliance and a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating proceduresManage direct reportsProvide constructive feedback and guidance to develop leadership in direct reports and department managementEstablish and monitor objective annual goals for direct reportsConduct performance reviews and establish performance improvement plans as neededRecruit, interview, and select personnel for hireTravel domestically up to 25% to attend offsite meetings, conferences, and support business initiativesMaintain acceptable attendance and punctuality for scheduled work hours and meetingsEnsure completion of assigned tasks and responsibilities within defined timeframesMaintain flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessaryPerform other duties as assignedSkillsKnowledge of FDA's Quality System Regulations, and the Canadian Medical Device RegulationsAbility to manage multiple complex problems simultaneouslyAbility to be flexible in changing daily workload priorities as directedAbility to coordinate and synchronize multiple projectsAbility to conduct a significant amount of planning activities for self and othersAbility to take initiative and make decisions within company/departmental guidelinesAbility to thrive under challenging deadlines and in an energetic environmentAbility to work independently and in a team environmentExcellent attention to detail and organizationExcellent written and verbal communicationHighest level of ethics and integrityAbility to lead and motivate the right behaviorsStrong technical writingEffective project managementProficiency in Microsoft OfficeQualifications/RequirementsBachelor's degree in a biological science, engineering, or related field requiredMaster's degree in a biological science, engineering, or related field preferredAt least 5-7 years of experience in an FDA regulated environment for medical device and/or pharmaceutical manufacturing, with at least 3-5 years in a management role for quality assurance, regulatory affairs, and/or engineeringASQ CQE certification preferredMust have DOE, Statistical Analysis, Quality System implementation, Quality Engineering Techniques, IQ/OQ/PQ, QSR (GMP) and ISO experience. Knowledge of basic statistical and engineering principles is essentialClearance of favorable background investigation required