Quality Program Manager Jobs

Quality Program Manager - Verathon®

Verathon® is looking for a Quality Program Manager to become the newest member of our Regulatory Affairs / Quality Assurance Team located in Bothell, WA. This s a hybrid role, working Monday, Tuesday and Thursday in office.

The Quality Program Manager 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 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 will be an advocate for cross functional collaboration, continuous improvement, process standardization, and compliance, with the goal of driving continuous quality system process performance.

Principal Responsibilities:

• Serve as CAPA process leader, Chair of CAPA Review Boards, and be the CAPA champion across Verathon
• 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
• Address any lack of compliance and potential areas of compliance vulnerabilities.
• Provide a clear vision of CAPA compliance across the company through collaboration, strategy, direction, management, and oversight of the global CAPA program.
• Provide metrics and reporting to cross-functional peers and partners.
• Identify and escalate any compliance issues and their potential impact cross-functionally, so that they can be effectively resolved
• Present to FDA, Notified Body, or senior executive leadership on the overall status and performance of the CAPA process
• Provide training, as required, to manage QMS processes.
• Manage multiple programs/projects from inception through completion to meet or exceed budget, schedule, and scope/quality requirements
• Ensure that CAPAs meet or exceed all internal and external regulatory requirements
• Monitors cost and schedule performance to baseline plans, takes action to manage risk, and deploy resources to achieve objectives
• 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)

Knowledge, Skills, and Abilities:

• Strong collaboration and influencing skills – able to lead cross functionally without direct authority
• Ability to work comfortably at all levels within the organization up to the senior management level required
• Bachelor's degree required, preferably in engineering or science
• Strong desire to work within a collaborative, productive, and empowered team
• 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
• Experience with working in a global environment preferred
• Strong written and verbal communication and presentation skills required

If you’re currently reading this and hesitating to click “Apply” because you don’t check all the boxes, we encourage you to go for it! A true passion and excitement for making an impact is just as important to us as work experience.

Salary range - $102,600 - $143,000 (Compensation will vary based on skills, experience and location. If this position is filled outside the Seattle WA metro area, this salary range will vary depending on the specific hiring location.)

Full-time non-sales employees are eligible for Verathon’s annual bonus plan based on company and individual performance.

Verathon provides a competitive benefits package including medical, dental, vision, basic life insurance, paid holidays, paid time off and a 401(k) matching plan. For more information, please visit our complete Benefits Summary at https://www.verathon.com/US-HQ-Employee-Benefits-Summary.

About Verathon:
Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com.

Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success. In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Verathon will be based on merit, qualifications, and abilities. Verathon does not discriminate in employment opportunities or practices on the basis of race, color, religion, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.

JOB DESCRIPTION / TEMP-0268 / REV-00