Sr. Director, Quality Assurance - Endoscopy

Work Flexibility: Hybrid or Onsite

Basic Function

• Set the vision, strategy, and direction for the Business Unit Quality Organization

• Provide Business Unit leadership as part of the Business Unit General Manager’s leadership team.  Along with cross-functional leadership team, support the direction, strategy, and growth of the business unit. 

• Accountable for ensuring the launch and distribution of quality products, compliance with all applicable quality and regulatory compliance requirements, maintaining product supply and providing positive customer experiences.

Responsibilities

• Will serve as a leader within the business unit as part of the business unit leadership team.  Participates in setting overall business unit strategy and goals.  Able to effectively communicate, influence, and navigate issues at the executive level.

• Participates on the Endoscopy Division Quality leadership team, helping set the strategy and direction for the overall Endoscopy Division Quality organization.

• Creates the vision and strategy for the organizations of responsibility to drive alignment with business priorities, efficiency, collaboration, and improved process and services.

• Hires, trains, supervises, mentors, motivates, and develops the leadership teams within each organization of responsibility.  Conducts performance management.

• Responsible for key metrics such as the Cost of Poor Quality, Customer Return Rate, Warranty Return Rate and Complaints per Million.  In collaboration with business and finance leaders, sets goals for these key metrics to drive appropriate customer satisfaction and acceptable financial performance within the business P&L.

• Accountable for the launch of high-quality products that meet user needs in new product design and development.

• Accountable to the review, monitoring and trending of customer complaints to identify actions to improve product quality.  Communicates directly with key customers when dealing with frustration or issues with our products.  Develops a quality organization that interacts regularly with customers and sales representatives.

• Sets the direction for the technical support organization, which provides prompt customer service for customer and sales rep calls for technical product assistance.  Maintains satisfactory metrics such as call wait time, call drop percentage, etc.

• Communicates regularly with cross functional business leaders including R&D, Marketing, Regulatory, Operations, Legal and Compliance.  Drives culture with onsite presence.

• Responsible for M&A due diligence activities from a quality perspective and influence into acquisition decisions; responsible for acquisition integration activities from a quality perspective.

• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.

• Responsible for supporting complaint handling, MDR-MDV reporting, and product field action decisions.

• Participates in external audits including direct interaction with FDA, ISO (Notified Bodies), and other external auditors. 

• Support Quality System activities including NC/CAPA, Internal Audit, and change control.

• May serve as Quality System Management Representative or alternative Management Representative.

Skills/Experience Required

• This is a management position that contributes and achieves results through others. The role is responsible for managing subordinates in professional jobs or managing through subordinate managers / supervisors or is a leader of process that achieves results through others, whom are not direct reports. Job requires a broad and comprehensive understanding in multiple disciplines relevant to the business. The job is expected to establish strategic plans and/or operational programs that require a sound understanding of the underlying theories underpinning the subject area. The job has full management responsibility including the management of numerous teams of managers/professionals, planning for the teams' future needs and operations. There will be financial accountability for independent budgets.

• Minimum of 15 years experience

• Minimum of 5 years of Management Experience

• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.

• Demonstrated expertise in quality systems in a regulated environment.

• Demonstrated project management skills.

• Demonstrated verbal, written, and interpersonal communicati