Director Quality Operations

This advertiser has chosen not to accept applicants from your region. The Director, Operations Quality oversees quality efforts from our suppliers to the distribution of our products, reflecting our core values of innovation, evidence, integrity, teamwork, respect, and a commitment to transplantation. This role is crucial in developing, establishing, and maintaining quality assurance and engineering programs, policies, processes, procedures, and controls to ensure that product performance and quality meet established standards and agency regulations. Guided by our vision, we are dedicated to transforming transplantation and achieving our mission of saving lives by making every donor organ count. In this position, the Director will have broad decision-making responsibilities and be accountable for the accuracy and timeliness of those decisions, as well as for deploying organizational resources to resolve issues. Reporting directly to the Vice President of Quality, the Director will collaborate closely with the Supply Chain, Manufacturing, and Distribution departments to create a cooperative environment that encourages teamwork and values each member's contributions. Responsibilities: Provide overall Quality Engineering leadership including: Setting the vision and direction of Site Quality Managers and their teams. Direct the activities of the Supplier Assurance Team. Oversee the activities of the Distribution Quality Team. Offer best-in-class expert level guidance and direction of the Quality Engineering Body of Knowledge. Create an inclusive learning environment within the Quality Team that is aligned to the company Values, Mission and aligned to business objectives. Lead and define Quality organizational business deliverables in support of the Product Development Process. Proactively identify opportunities to assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc. Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility. Provide leadership that is aligned with company Values and Mission Statement with peers and teams to drive proactive quality improvements. Identify Quality Initiatives and lead cross-functional teams to complete them. Communicate diligently and evidence-based communication to Executive Management team, peers, and team. Assess resource needs to assure that the appropriate level of quality support is provided when needed with the competencies needed. Oversee the Nonconformance and Real-time data management portions of the Quality System. Develop and continually improve a Supplier Management Program. Champion post-production risk management activities to include complaint investigation, risk analysis, and action deployment to resolve any issues. Be an effective member of the cross-functional leadership organization to foster continuous quality compliance, cost, and predictive measures improvements. Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance. Be a champion of Quality, and become the subject matter expert in Six Sigma, Lean and instill structured management process in problem solving throughout the organization. Requirements: Minimum BSc in Bioscience, engineering or equivalent or other related field. Master’s degree is preferred. 10+ years in quality desired with at least 3 years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment. Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required. Ability to travel Internationally to support supplier and manufacturing sites. Influential and inclusive leadership skills with a proven track record of creating momentum and delivering exceptional results within the framework of our values of teamwork and respect. Demonstrable project management skills with a passion for advancing quality, process improvement by winning through your team.

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