Director - Quality Systems

ESSENTIAL JOB FUNCTIONS  

This position is a leadership role focused on overseeing and enhancing Inspire’s global quality system.  This position involves leading teams responsible for configuration assurance, quality systems compliance, QMS training and audit, quality operations, non-product software design assurance and eQMS development and implementation, ensuring compliance with global regulations and driving continuous improvement.

The position will collaborate with multiple stakeholders across the organization, including design assurance and post market quality leaders, operations, information services, product development and regulatory to achieve organizational goals and foster a high-performing workplace.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE  

• Lead and maintain an effective quality system which includes a strategic QMS structure, quality planning activities, execution and monitoring of all QMS processes and metrics.
• Develop and implement the annual quality plan, quality objectives and quality metrics that drive business objectives, continuous improvement and compliance to global regulations.
• Lead the development and implementation of new electronic QMS process workflows to drive compliance with current regulations as well as new geographic regulations where products are, or planned to be, distributed.
• Manage teams interacting with external agencies (FDA, Notified Bodies, and Competent Authorities) for inspections and compliance audits.
• Provide quality expertise for non-product software validations (including ERP/MRP tools) and lead quality assurance teams supporting non-product software validations.
• Lead QMS continuous improvement projects to increase efficiency of the QMS and drive organization compliance.
• Perform, support, mentor and coach others on effective root cause investigations and CAPA actions to maintain effective and compliant quality systems and products.
• Ensure QMS competency-based learning is in place for all QMS processes for both Inspire employees and contractors.
• Recruit, coach, mentor and develop top talent for the quality team.
• Lead effective change management across the organization.
• Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
• Complete training requirements and competency confirmations as required for this position within the required timeline.
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
• Ensure all direct reports maintain training records that comply with applicable quality system requirements.

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required: 

• Minimum of 15 years working in medical device quality systems
• Minimum of 10 years managerial experience
• Minimum of 5 years in a medical device compliance and/or audit role
• Experience working directly with FDA, Notified Bodies or other geographic regulators during regulatory inspections/audits (front room)
• In depth knowledge of and implementing global medical device regulations (21 CFR 11, 820, 801, 803, 806, 821, 822, 830, JPAL, EU MDR, MDSAP, ISO 13485, etc.)
• Demonstrated leadership and project management skills with the ability to prioritize and execute.
• Proficient with Microsoft Word, Excel, and PowerPoint.
• Proficient with other MS applications (i.e.; Power BI, SharePoint, OneDrive, etc.)

• Bachelor’s degree in science, engineering, technology, or biomedical discipline

Preferred:

• 15 years’ experience in a medical device quality management role.
• 5 years managing electronic QMS system/workflow implementations
• 5 years working with nonproduct software validation requirements
• Experience working directly with FDA, Notified Bodies or other geographic regulators on product recalls.
• Demonstrated QS leadership by:
  • Implementing and obtaining certification (FDA & ISO) of a quality management system.
  • Implementing and validating an electronic QMS software tool to transition existing paper processes into electronic workflows.
• Demonstrated high level of strategic thinking, customer/patient focused risk assessment and judgement.
• Demonstrated creative and effective problem solving and out of the box thinking for quality system and compliance solutions.
• Strong interpersonal and communication (both verbal and written) skills. Ability to facilitate teams and deliver presentations.
• Effective relationship management, ability to network, support and influence across the entire organization.
• Proven success in coaching, developing, and managing people.

• Master’s degree in a technical or scientific field

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