Manager, Quality Management Systems

TRIMEDX•Indianapolis, IN

1d•Hybrid

About The Position

If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care and performance. Everyone is focused on serving the customer and we do that by collaborating and supporting each other Associates look forward to coming to work each day Every associate matters and makes a difference It is truly a culture like no other — We hope you will join our team! Find out more about our company and culture here. The Manager, Quality Management Systems, is responsible for managing and maintaining the TRIMEDX Quality Management System (QMS) in adherence to ISO 13485, ISO 27001, as well as regulatory standards requirements. The role is responsible for sustaining the QMS and culture of patient safety, quality and compliance culminating in certification. The manager will ensure policies, procedures, instructions, forms, and objectives are developed in collaboration with functional leaders and subject matter experts to be both compliant to relevant ISO standards as well as supporting existing business processes and strategies. This Manager will demonstrate proven leadership skills and guide the application of the QMS while supporting business growth. As a QMS champion and change agent, this role is responsible for the application of the QMS principles, quality improvement optimization, and ongoing monitoring of TRIMEDX process performance results and program standards. Location: Indianapolis, Indiana; candidates must currently reside in central Indiana, within a 70 mile range of Indianapolis. Our Central (Corporate) Office is located on the northwest side of Indianapolis. Position is hybrid (a mix of in-office, remote, as well as required business travel). Relocation is not available for this position Immigration sponsorship not available for this position

Requirements

Minimum of 5 years of experience managing and deploying successful QMS programs, and a minimum of 3 years of experience in managing others. Strong equivalent experience leading others indirectly will be considered for this role.
Experience and expertise with ISO standards preferred, specifically ISO-9001 and/or ISO-13485 preferrable.
Internal audit and CAPA experience; lead auditor certification is preferred.
Six Sigma or Lean experience in healthcare environment is preferred.
Up to 15% travel is expected.
Ability to streamline processes and determine value add, non-value add activities
Knowledge of implementing ISO 13485 and/or 27001 and other applicable Regulations and Standards
Results orientation driven by KPIs and metrics, knowledge of statics and analytical tools
Able to champion the vision of change as an opportunity and overcome resistance
Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.
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) and project management skills.
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 is required.

Responsibilities

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.
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.