Senior Director, Site Quality, Waukesha South Operations

Overview

Job Description Summary. This role will be responsible for overall Quality Assurance activities at the Waukesha South Operations (WSO) facility. The WSO facility designs and manufactures finished medical devices within the Imaging segment. The Senior Director, Site Quality, will be responsible for developing and maintaining systems, rules, and processes to ensure fulfillment of internal and external requirements. They ensure that projects and products are capable and will meet specified standards.

The leader shall have an in-depth knowledge of best practices and how their own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market.

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

• Leads a team of quality professionals who support the overall site Quality Management System, Design Quality and Production and Process Control Quality.
• Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics.
• Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
• Displays deep expertise within quality, providing professional or thought leadership. Defines and influences policy and ensures delivery within quality, linking with other functions of the organization.
• Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
• Will lead cross-functional teams and projects with moderate to high resource requirements, risk, and/or complexity. Presents solutions to leaders in quality and other functions at the site.
• This role has a major influence on quality decisions and operating guidelines impacting the site.
• Uses high level of judgment to make decisions and handle complex tasks or problems that impact quality. Has ability to assess quality of information given and ask pertinent questions to stakeholders.
• Able to offer new solutions to problems outside of set parameters and can construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
• Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.

• Bachelor's Degree or a minimum of 14 years work experience.
• Minimum of 10 years working in a regulated medical device or pharmaceutical industry.

• Strong leadership and communication skills. Previous project management experience is preferred. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls;
  Corrective & Preventive Action (CAPA), complaints & risk management.
• Demonstrated collaboration, negotiation & conflict resolution skills. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance. Demonstrated understanding of product development life cycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.…