Sr. Director, Product Quality

OverviewSenior Director, Product Quality leads and manages global product quality activities for the ACIST/BMT product lines across the entire product lifecycle. This role ensures strict adherence to FDA, ISO, and IEC regulations, standards, and design control procedures while driving excellence in quality and compliance.Key responsibilities include overseeing design assurance for hardware, software, and consumables; ensuring the highest product quality levels; integrating design control processes with risk management and human factors studies to enhance patient safety and product performance; leading verification and validation (V&V) activities; monitoring post-market product quality to drive continuous improvement; implementing and optimizing quality processes and tools to enhance product quality, regulatory compliance, and customer satisfaction; and overseeing in-house and external manufacturing quality, including contract manufacturing and supplier quality management for finished goods manufacturing.This role is a key leadership position and fosters a culture of quality, compliance, and continuous improvement, ensuring that all products meet the highest standards of safety, performance, and reliability. Primary Duties & Responsibilities: People LeadershipDirect and coordinate the day-to-day activities and projects of a team of professionals responsible for global product quality.Recruit, select and retain a high-performance team.Assign and monitor staff objectives and workloads to establish a high performing team.Promote employee development and foster growth of employees through performance management, skills development, continuous one-on-one feedback, bi-annual appraisal of individual performance, and recognition and motivational techniques/tools to drive high levels of employee performance and engagement.Coaching and mentoring of staff; oversee and/or conduct training of new and existing employees and facilitate assimilation of new members and changes.Identify resource needs (human, equipment, etc.) for improvement as needed and for future growth projections to support a growing business.Establish clear SMART goals and objectives to determine individual and team results.Drive continuous improvement in key operational metrics and achievement of organizational goals.Provide a communication forum for the exchange of ideas and information with the department; encourage input from team members.Ability to work effectively in a high-matrix organization and establish strong working relationships across Bracco. Design Assurance ManagementProvide leadership with strategic insight, directing and implementing all design quality engineering activities related to the existing commercialized product and new product introductions.Develop and implement design assurance processes to deliver consistent outputs across the team.Guide quality staff and leaders within product development teams regarding quality characteristics and conformance to product requirements including software, electrical, mechanical, and consumable products.Guide application of internal development procedures, including Design Control and SDLC, within regulatory requirements.Oversee design verification and validation activities to ensure proper qualification of the design and readiness for transfer to operations for scale-up.Oversee generation of QA deliverables to meet project scope and plan; review, input, and approve project-related deliverables and change orders.Collaborate with external design/test organizations when needed to fulfill Design Control requirements and establish appropriate supplier controls. Product Quality EngineeringProvide leadership with strategic insight, directing and implementing all quality engineering activities for existing commercialized products and product improvements, aligned with the company vision of device portfolio management.Lead and direct all aspects of commercialized product quality, using sound judgment for decisions involving science, engineering, risk management, and knowledge of healthcare and product-use environments.Direct continuous improvement of product quality and reduction of waste.Oversee manufacturing quality operations, including subcontracted processes, internal production, and test processes/release.Participate in or lead forums related to quality metrics, cost of quality, master validation plans, QC inspection/release, nonconforming material, complaint investigations, process FMEA and change control.Identify, develop and retain engineering talent; ensure high standards in recruiting and retention. Supplier Quality - Finished Goods and Component ManufacturingEstablish and maintain a supplier quality management process that ensures product reliability and performance while reducing waste and controlling costs.Partner with the head of operations to establish strategic supplier plans and objectives; decide on supplier quality matters and ensure quality objectives are met.Oversee supplier performance for component providers to ACIST production facilities and participate on the supplier review board.Report to senior leadership on all quality aspects of supply chain management from supplier evaluation and performance to finished goods testing and release, driving continuous product improvement. Does this position have supervisory authority? Yes No Qualifications (Knowledge, Skills & Abilities): MinimumB.S. in Engineering or related discipline.15 years of experience in the Quality Engineering/Design Assurance capacity in the medical device industry including software-driven electronic devices and associated consumables.Demonstrated success in building a high-performing team including a minimum of 8 years of management experience.Strong working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.Demonstrated leadership skills and knowledge of ISO 14971, IEC 60601-1 and related standards.Proficiency in statistical methods (ANOVA, SPC, sampling plans, gauge R&R, DOE) and quality principles/best practices.Moderate computer proficiency (MS Word, Excel, Project, database, and statistical software).Effective oral and written communication and technical writing skills; demonstrated negotiating skills.Documented history of high performance results; ability to travel domestically and internationally. Preferred:M.S. degree in Mechanical, Electrical, Software or Design Engineering; MBA.ASQ CQE or Six Sigma certification.Demonstrated knowledge of pre-market submissions in the U.S. and Europe. Other:Self-Awareness and Self-RegulationOrganizational AwarenessSocial IntelligenceInspire TrustFost InclusivityIntroduce and Manage Change #J-18808-Ljbffr

Created: 2025-10-06