Quality Program Manager III

Verathon, Inc. • Bothell, WA

3d • $104,061 - $134,316

About The Position

Verathon® is looking for a Quality Program Manager III to become the newest member of our Regulatory Affairs / Quality Assurance Team located in Bothell, WA.
The Quality Program Manager III is responsible for defining, structuring, and leading cross functional projects and programs with a focus on product quality, compliance, and continuous improvement of the Quality Management System (QMS). The Quality Program Manager III is also responsible for the management and implementation of global Corrective Action/Preventive Action (CAPA) policy, strategy, systems, and efficiency tools. The Quality Program Manager III will be an advocate for cross functional collaboration, continuous improvement, process standardization, and compliance, with the goal of driving continuous quality system process performance.

Requirements

• Bachelor's degree required, preferably in engineering or science
• 5+ years’ experience in one or more of the following areas: Quality Assurance, Product Development, Lean Manufacturing, Supplier/Manufacturing Operations required
• 3+ years’ expertise with Corrective Action and Preventative Action and/or Continuous Improvement Manager preferred
• Strong collaboration and influencing skills – able to lead cross functionally without direct authority
• Strong written and verbal communication and presentation skills required
• Ability to work comfortably at all levels within the organization up to the senior management level required
• Strong desire to work within a collaborative, productive, and empowered team
• Experience with working in a global environment preferred

Responsibilities

• Manage multiple programs/projects from inception through completion to meet or exceed budget, schedule, and scope/quality requirements
• Uses robust project planning tools for maintenance, tracking, and communication of projects (e.g. Work Breakdown Structure, Gantt chart, risk logs, responsibility assignment matrix/RACI chart)
• Monitors cost and schedule performance to baseline plans, takes action to manage risk, and deploy resources to achieve objectives
• Serve as CAPA process leader, Chair of CAPA Review Boards, and be the CAPA champion across Verathon
• Provide a clear vision of CAPA compliance across the company through collaboration, strategy, direction, management, and oversight of the global CAPA program.
• Ensure that CAPA policies and procedures continue to meet all applicable requirements and regulations, including but not limited to FDA 21 CFR Part 820, ISO 13485:2016, MDSAP, and other applicable international regulations
• Ensure that CAPAs meet or exceed all internal and external regulatory requirements
• Identify and escalate any compliance issues and their potential impact cross-functionally, so that they can be effectively resolved
• Address any lack of compliance and potential areas of compliance vulnerabilities.
• Provide training, as required, to manage QMS processes.
• Provide metrics and reporting to cross-functional peers and partners.
• Present to FDA, Notified Body, or senior executive leadership on the overall status and performance of the CAPA process

Benefits

• Verathon provides a competitive benefits package including medical, dental, vision, basic life insurance, paid holidays, paid time off and a 401(k) matching plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees