Sr. Director, Product Quality

Sr. Director, Product Quality

Why Join Bracco Medical Technologies? We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day! The Senior 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 of this role 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 and 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; 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 must for fostering a culture of quality, compliance, and continuous improvement, ensuring that all products meet the highest standards of safety, performance, and reliability. Primary Duties & Responsibilities include: People Leadership, Design Assurance Management, Product Quality Engineering, and Supplier Quality - Finished Goods and Component Manufacturing.

Qualifications (Knowledge, Skills & Abilities): Minimum B.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. Demonstrated knowledge and proficiency in the application of ISO 14971, IEC 60601-1 and other standards related to product design and development. Skilled in the application of statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments. Demonstrated knowledge and proficiency in quality principles and best practices. Moderate level of computer proficiency including MS Word, Excel, Project, database, and statistical applications software. Effective oral and written communication skills. Effective technical writing skills Demonstrated negotiating skills Documented history of high performance results in previous positions. Ability to travel both.

ACIST Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Refer to ID 85005581 when applying.