Sr. Director, Quality Assurance Eden Prairie, MN, US

Sr. Director, Quality Assurance

At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose patients. Our unique line of products includes Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR), Cardiovascular Imaging contrast delivery (CVi), and CT and MRI contrast delivery systems.

Position Description

Position Summary : 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 :

People Leadership Direct 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 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, addition of capabilities, and future growth projections to support a growing business. Establish clear SMART goals and objectives by which to determine individual and / or team results. Drive individuals and the team to continuously improve in key operational metrics and the achievement of the organizational goals. Provide communication forum for the exchange of ideas and information with the department. Ask questions; encourage input from team members. Ability to work effectively in a high matrix organization and establish strong working relationship across Bracco.

Design Assurance Management Provide strong 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 ensure efficient, effective and consistent outputs across the team. Provide direction to quality staff and leaders within the product development teams regarding quality characteristics and conformance to product requirements including software, electrical and mechanical as well as consumable products. Provide guidance to quality staff and leaders within the product development teams for the application of internal development procedures, including Design Control and SDLC, within the framework of regulatory requirements. Oversee design verification and validation activities to ensure product development teams have appropriately qualified the design and it is ready for transfer to operations for further scale-up. Oversee the generation of QA deliverables to meet the project scope and plan. Review, provide input and approve project-related deliverables and change orders. As required, work with external design / test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place to perform the work.

Product Quality Engineering Provide strong leadership with strategic insight, directing and implementing all quality engineering activities related to the existing commercialized product and product improvement, in alignment with the ACIST corporation vision of device portfolio management. Lead and direct all aspects of commercialized product quality, using sound judgment to make important and difficult decisions that may involve science and engineering, business risk management, and knowledge of healthcare and product-use environment, using all available sources of internal and external information including customer product experience. Direct continuous improvement of product quality and reduction of waste. Oversee manufacturing quality operations, including subcontracted processes, internal production, and test processes / release. Participate and in some cases 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 to achieve deliverables. Ensure high standards in recruiting and retention.

Supplier Quality Finished Goods and Component Manufacturing Establish and maintain a supplier quality management process that ensures product reliability and performance while reducing waste and controlling costs. Partner with head of operations to establish strategic supplier plans and objectives, making decisions on supplier quality matters and ensuring quality operations' effective achievement of objectives. Oversee the supply chain performance of 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, in a manner that drives continuous product improvement.

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 domestically and internationally

Preferred : M.S. degree in Mechanical, Electrical, Software or Design Engineering MBA ASQ CQE (Certified Quality Engineer) or 6 Sigma discipline. Demonstrated knowledge of pre-market submission in U.S and Europe.

Other : Self-Awareness and Self-Regulation Organizational Awareness Social Intelligence Inspire Trust Foster Inclusivity Introduce and Manage Change

Compensation & Total Rewards :

Estimated Starting Salary Range : $167,000 - $265,000

• Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.

Total Rewards :

Job Location

7905 Fuller Road, Eden Prairie, Minnesota

Tracking Code

1401-432