Senior Quality Systems Specialist

Build a career that makes an impact.

At hu Mannity Medtec, you don't just build a career, you help change lives.

Build a career that makes an impact.

At hu Mannity Medtec, you don't just build a career, you help change lives.

For over 40 years, we have been advancing life-enhancing medical technologies that address unmet healthcare needs. Our teams bring together engineering, science, and clinical expertise to transform bold ideas into solutions that can make a difference for patients around the world.

We believe meaningful work and a balanced life go hand in hand. That is why we offer a 9/80 schedule, giving our employees every other Friday off. That means 26 extra long weekends each year to recharge, spend time with family and friends, pursue hobbies, or simply enjoy more balance outside of work.

Why hu Mannity Medtec?

Mission-driven work that impacts lives

A 9/80 schedule with every other Friday off (26 long weekends a year!)

Collaborative teams solving complex challenges

Opportunities to learn, grow, and make an impact

Weekly team traditions, monthly lunches, and quarterly events that bring us together

Position Summary

We are seeking an experienced Senior Quality Systems Specialist to support and continuously improve our Quality Management System (QMS) while ensuring compliance with ISO 13485:2016, applicable regulatory requirements, and company quality objectives.

This role serves as a Quality Systems Subject Matter Expert (SME), partnering with Research & Development, Manufacturing, Quality Assurance, and cross-functional teams to promote a culture of quality and compliance throughout the organization. The ideal candidate is highly organized, detail-oriented, and passionate about building effective quality systems that support operational excellence, audit readiness, and continuous improvement.

Essential Duties And Responsibilities Quality Management System (QMS)

• Develop, implement, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, regulatory requirements, and company procedures.
• Serve as the Quality Systems Subject Matter Expert (SME) and provide guidance on quality system requirements and best practices.
• Develop, revise, and maintain SOPs, work instructions, forms, templates, and other controlled documents.
• Review and approve quality system documentation to ensure consistency, accuracy, and compliance.

• Plan, schedule, coordinate, and conduct the internal audit program.
• Prepare audit reports, communicate findings, and support follow-up activities.
• Serve as the primary coordinator and host for external audits, including ISO certification and surveillance audits.
• Support organizational audit readiness by preparing documentation and coordinating cross-functional activities.
• Track audit observations and nonconformances through closure and effectiveness verification.

• Support the CAPA program by facilitating investigations, root cause analysis, corrective actions, and effectiveness checks.
• Collaborate with cross-functional teams to resolve quality system issues and improve compliance.
• Lead QMS improvement projects and process optimization initiatives.
• Identify opportunities to improve efficiency, effectiveness, and overall quality system performance.

• Develop, monitor, analyze, and report Quality Objectives, KPIs, and quality system metrics.
• Create dashboards, trend analyses, and reports to support decision-making and continuous improvement activities.
• Lead preparation of Management Review materials by collecting and analyzing quality system data.
• Present trends, metrics, and recommendations that support executive review and business objectives.

• Provide guidance, coaching, and training on quality system requirements, processes, and procedures.
• Partner with Manufacturing, Engineering, Quality Assurance, and R&D teams to promote compliance and process consistency.
• Support company-wide initiatives that strengthen quality culture and operational excellence.
• Act as a resource for interpreting quality system requirements and regulatory expectations.

• Bachelor's degree or equivalent combination of education and experience.
• Minimum of 10 years of combined practical and educational experience within the medical device industry.
• Hands-on experience maintaining and improving Quality Management Systems.
• Strong working knowledge of ISO 13485:2016 requirements.
• Excellent…