Quality Leader — Medical Devices & Compliance

In September 2024, Morgan Scientific Incorporated (MSI) joined the Vitalograph group of companies as a wholly owned subsidiary. Vitalograph – a global leader in respiratory diagnostics – has had a long and enduring relationship with Morgan Scientific. For both companies, the decision is a natural progression as the combined expertise allows the enlarged organisation to focus on delivering the best possible diagnostic solutions that can enable a better understanding of lung health.

The acquisition of Morgan Scientific is a key milestone in Vitalograph’s plan to develop its respiratory diagnostics business globally, furthering its goal of providing comprehensive testing solutions that enable the best possible respiratory healthcare. Vitalograph is in the middle of an ambitious growth strategy and is on track to treble its respiratory diagnostics business in the four years leading to 2026.

Why Join Us?
We believe in fostering a supportive environment that values both personal and professional growth. When you join us, you’ll enjoy a comprehensive benefits package designed to help you thrive:

• 401(k):
Secure your financial future with our robust retirement savings plan.

• Health Insurance:
Comprehensive coverage to keep you and your family healthy.

• Paid Time Off:
Enjoy a healthy work-life balance with generous leave.

• Comprehensive training in respiratory diagnostic products and healthcare installation standards.

• Opportunities for professional development and career advancement in a dynamic and innovative company

• Tuition Reimbursement:
Continue your education with financial backing from us.

We are now recruiting for aQuality Manager in Lenexa, Kansas. This is a key leadership role within the business, with the opportunity to shape, strengthen and continuously improve our Quality culture and systems.
The Quality Manager will maintain the Quality Management System, ensuring the business remains compliant with applicable FDA 21 CFR Part 820 and ISO 9001 requirements, while driving a practical, proactive approach to Quality across the organisation.
We are looking for someone who is hands-on, solutions-focused and passionate about continuous improvement. This is not a role that simply manages paperwork or reacts to issues — it is an opportunity to work closely with teams across the business, identify opportunities to improve processes, facilitate positive change and ensure Quality is embedded into everything we do.

What you’ll be responsible for

• Maintain the Quality Management System, including the development, review and continual improvement of policies, procedures and documentation.

• Lead and coordinate internal, third-party and supplier audits, ensuring the business remains audit-ready and supports successful regulatory inspections.

• Manage CAPA, Non-Conformances and Change Controls, ensuring issues are investigated effectively and improvements are implemented and sustained.

• Chair Management Reviews and Quality System meetings, providing clear direction, actions and follow-up.

• Oversee training, competency and resource requirements within the Quality function.

• Analyse Quality data and trends to identify risks, opportunities and areas for improvement.

• Manage customer feedback and ensure appropriate tracking and follow-up.

• Maintain effective device traceability and associated Quality records.

• Produce clear, accurate and meaningful Quality reports for management.

• Support regulatory and standards compliance, including FDA and ISO 9001:2015 requirements.

• Champion a culture of continuous improvement, working collaboratively with teams to improve processes, reduce risk and raise standards.

• Support training tracking and relevant compliance requirements, including HIPAA where applicable.

What…