TRIMEDX · 8 hours ago
Manager, Quality Management Systems
Indianapolis, IN
Full-time
Hybrid
Mid, Senior Level
5+ years expTRIMEDX is a company focused on quality management in healthcare, and they are seeking a Manager for their Quality Management Systems. The role involves managing and maintaining the QMS in adherence to ISO standards and ensuring a culture of patient safety and compliance while supporting business growth.
Asset ManagementHealth CareHospital
No H1B
Responsibilities
Execution of the QMS (50%)
Leads quality initiatives focused on evolving the QMS in adherence to ISO 13485, ISO 27001, and applicable regulatory requirements
Development and management of the TRIMEDX Internal Audit program, planning, and execution in adherence to ISO 13485, 27001 and/or applicable regulatory standards
Demonstrate strong collaboration, including problem solving and continuous improvement efforts, and communication regarding the QMS and ISO methodology throughout the TRIMEDX organization
Manages the Corrective Action and Preventive Action program activities and database
Provides oversight of the QMS risk management and change control processes and implementation throughout the organization
Facilitate and manage preparation activities, action item follow-up, meeting minutes and presentation of the Quality Management Reviews
Provide input to creation of company and department ISO objectives regarding compliance and effectiveness of the QMS
Manage and maintain all QMS databases
Provides coaching and guidance to TRIMEDX associates and leaders regarding QMS and ISO methodology
Leadership (50%)
Apply knowledge and experience with ISO standards and regulatory requirements to oversee creation, implementation, adoption, and effectiveness of the QMS across the organization
Plan, implement, and evaluate department and team goals and ensure on-time execution
Demonstrate and instill change management culture throughout the team, as well as throughout the organization
Provide leadership and role modeling through community involvement and a commitment to living out the company’s core values
Champion key QMS improvement initiatives
Provide oversight to the QMS team regarding departmental expenses
Leadership: Provide clear direction to ensure collective achievement of goals and objectives. Create an environment of respect, collaboration, and open communication
Associate Development: Identify and support development needs of direct reports and team members including connecting them to resources both internally and externally to ensure a culture of continuous improvement
Associate Engagement: Create high levels of employee engagement by understanding organizational and personal drivers that impact drivers and developing action plans that deliver increased engagement
Performance management: Set clear goals and expectations for teams, monitor, and enable performance and intervene with appropriate action when performance gaps occur and provide timely, honest feedback. Ensure that associates complete assigned actions by required deadlines
All other duties as assigned
Qualification
Required
Minimum of 5 years of experience managing and deploying successful QMS programs
Minimum of 3 years of experience in managing others
Experience and expertise with ISO standards preferred, specifically ISO-9001 and/or ISO-13485
Internal audit and CAPA experience
Lead auditor certification
Knowledge of implementing ISO 13485 and/or 27001 and other applicable Regulations and Standards
Results orientation driven by KPIs and metrics
Proven analytical and problem-solving skills to diagnose and resolve issues
Demonstrated understanding and use of Document Control and/or QMS software
Organizational and time management skills
Strong interpersonal and conflict management skills
Strong communication skills (written, verbal and presentation)
Change leadership experience working across teams and functions
Ability to lead, motivate, and develop others both directly and indirectly
Knowledge of Microsoft Office applications required (Intermediate to Advanced preferred)
Bachelor's degree in business, engineering, healthcare technology management or related field, or equivalent experience
Preferred
Experience and expertise with ISO standards preferred, specifically ISO-9001 and/or ISO-13485
Internal audit and CAPA experience; lead auditor certification is preferred
Six Sigma or Lean experience in healthcare environment is preferred
Knowledge of Microsoft Office applications required (Intermediate to Advanced preferred)
Company
TRIMEDX
TRIMEDX is a provider of clinical engineering, medical device cybersecurity and clinical asset management solutions.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$0.2M2014-01-21Debt Financing· $0.2M
Leadership Team
Neil de Crescenzo
Chief Executive Officer
Christopher Dunkerley
CFO
Recent News
2025-09-17
Company data provided by crunchbase