Quality Leader — Medical Devices & Compliance

Vitalograph; Lenexa (KS); Hybrid; USD 85.000 - 120.000; Vollzeit

Benefits dieser Stelle

401(k)

Health Insurance

Paid Time Off

Comprehensive training

Tuition Reimbursement

Zusammenfassung

Vitalograph in Lenexa, KS is seeking a hands-on Quality Manager to lead our Quality Management System, driving continuous improvement and ensuring FDA 21 CFR Part 820 and ISO 9001 compliance. This role works cross-functionally to embed quality into daily operations, manage audits, CAPA, change controls, and metrics, while coaching teams toward robust processes.

If you have senior Quality leadership experience in regulated environments, you will help sustain the highest standards and support

Qualifikationen

• Degree in Quality Management or significant senior-level experience in a regulated environment.
• Experience with FDA 21 CFR Part 820 and ISO 9001 requirements.
• Strong auditing, leadership and change-control skills.

Aufgaben

• Maintain the Quality Management System with policies, procedures and docs.
• Lead audits (internal, supplier, third-party) and support regulatory inspections.
• Manage CAPA, Non-Conformances and Change Controls to ensure lasting improvements.
• Chair Management Reviews and Quality System meetings with clear follow-up actions.
• Oversee training, competency and resource planning within Quality.

Kenntnisse

Quality Management

Auditing

Regulatory Compliance

Leadership

CAPA & Change Control

Ausbildung

Degree in Quality Management or related field

Jobbeschreibung

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 we’re looking for
We’re looking for an experienced Quality professional who can combine strong technical knowledge with confident leadership and a practical, hands-on approach.

You will ideally have:
• A degree or significant senior-level Quality Management experience within an ISO 9001-certified medical device, pharmaceutical or similar regulated environment.
• Quality Management and Auditing qualifications.
• Strong experience of QMS implementation, maintenance and continual improvement.
• Experience conducting and hosting internal, customer, supplier and third-party audits.
• Knowledge of medical device and/or pharmaceutical manufacturing environments.
• Experience with FDA registration, UDI and listing processes.
• A strong understanding of Quality Control, regulatory requirements and compliance.
• Experience developing and implementing policies, procedures and Quality systems.
• Proven experience leading Quality initiatives and driving measurable process improvements.

The person
Most importantly, we're looking for someone who will be a visible Quality leader and advocate for improvement.
You’ll be someone who gets involved, understands what is happening on the floor, builds strong relationships with colleagues and isn't afraid to challenge existing processes when there is a better way of doing things.
You will act as a facilitator, coach and advocate for Quality, helping teams understand not just what needs to be done, but why it matters.
This is an opportunity for an experienced Quality professional to have a genuine impact — strengthening our Quality culture, improving the way we work and helping the business continue to grow while maintaining the highest standards. Apply Now

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