Clinical Engineering Regulatory & Quality Operations Manager

Seeking a Clinical Engineering Regulatory & Quality Operations Manager with 8-10 Yrs exp in Healthcare Tech Mgmt.

Purpose: Frontline, department‑based leader responsible for supervising daily functions, advancing people and processes, and supporting structures and programs that impact direct and indirect patient care. This role models behaviors aligned with organizational culture, drives comprehensive strategies, and measures progress toward defined outcomes.

Must have a valid US driver's license and good driving record.

Must be able to work in the US without Visa sponsorship and have a US Driver's License.

COMPLETE BACKGROUND CHECK AND DRUG SCREENING REQUIRED.

Essential Functions

Leadership

• Provide strategic advice, guidance, and leadership to staff and regional leaders to support performance goals.
• Enable collaboration across service areas, staff, and regions to ensure consistency, integration, and alignment of strategy and operations.

Direction & Growth

• Offer leadership and subject‑matter guidance to service areas, functional teams, RHMs, and Regions.
• Lead standardization and optimization of policies, processes, and methodologies; establish and maintain a national community of practice.
• Oversee Vendor/Contract Labor Management, including centralized strategy development and spend optimization.

Strategic Support & Accountability

• Collaborate on system‑wide strategy development and deployment of functional priorities and initiatives.
• Support regional compliance with functional priorities and operational expectations.
• Accountable for selection, evaluation, and overall success of functional leadership teams.
• Serve as the organizational focal point for functional strategy, financial governance, and staffing oversight.
• Ensure clear communication between service areas, functional teams, staff, and regional leadership.

Operational Delivery

• Measure, track, and report KPIs, metrics, and value delivery.
• Provide leadership and guidance across the colleague lifecycle.
• Maintain working knowledge of federal, state, and local regulations, the Integrity & Compliance Program, Code of Conduct, and all relevant policies to ensure ethical, professional, and safe work practices.

Functional Responsibilities

• Support national services, system‑level operations, field teams, and cross‑functional departments to achieve CE program goals and priorities.
• Partner with the National Director and CE leadership to define, maintain, track, and implement quality processes and standards.
• Lead and participate in quality planning, assurance, control, and continuous improvement activities.
• Develop and maintain national standards, guidelines, processes, and strategies that address internal/external business and regulatory requirements.
• Provide functional analysis expertise for monitoring performance measures and operational standards.
• Stay current with industry developments, regulatory changes, and emerging standards; advise National Director accordingly.
• Monitor and support recurring operational processes such as annual Program Quality Evaluations (PQE) and alert/recall management to ensure timely completion and compliance.
• Participate in CE operations leadership huddles and work sessions to establish, document, and update Standards, Guidelines, and Work Instructions.
• Support National Director and Area Directors with onboarding of new service region acquisitions and divestitures; monitor transition milestones and communicate potential barriers.

Regulatory & Compliance Expertise

Provide research, interpretation, and guidance related to compliance with:

• Local, state, and federal regulations
• The Joint Commission (TJC) Environment of Care
• Association for the Advancement of Medical Instrumentation (AAMI)
• Cybersecurity and Infrastructure Security Agency (CISA)
• Other relevant regulatory bodies and industry standards

Minimum Qualifications

• Associate degree or equivalent in business administration, management, or related discipline.
• 5–10 years of progressive experience in healthcare technology management or a similar industry.
• Demonstrated success leading and managing professional teams; ability to motivate and inspire high performance.
• Strong ability to manage multiple projects and priorities effectively.
• Strategic thinker with strong problem‑solving skills.
• Excellent communication and interpersonal skills.
• Knowledge of relevant industry regulations, standards, and best practices.