Manager Clinical Engineering Regulatory & Quality Operations

Position is located at System Office, Livonia, MI

Purpose

Frontline, department-based; Supervises daily functions of assigned department; Provides clear direction & manages / advances people, processes, structures &/or programs that support direct / indirect care. The leader demonstrates behaviors in alignment with culture & creates / supports comprehensive strategies & measures progress to achieve desired outcomes.

Note: “patients” refers to patients, clients, residents, participants, customers, members

Essential Functions 

Our Trinity Health Culture:

• Knows, understands, incorporates & demonstrates our Trinity Health Mission, Values, Vision, Actions & Promise in behaviors, practices & decisions.

Leadership

• Providing advice, guidance, and leadership to RHM and Region leaders in developing strategies and in the achievement of performance goals.
• Enable Collaboration across and within service area, RHM, and Regions to ensure consistency and integration of strategy and operations.

Direction and Growth
Providing advice, guidance, and leadership to service area, functional area, RHM, and Regions.

• Leading standardization/systemness and optimization of policy, process, methodology, establishing a national community of practice.
• Oversee Vendor/Contract Labor Management including centralizing strategy and optimizing spend.

Strategic Support & Accountability

• Collaborates in system-wide strategy development and deployment of functional area priorities and initiatives.
  Responsible for supporting regional efforts to comply with functional area priorities.

• Accountable for the selection, evaluation, and overall success of the functional leadership teams.
• Organization-wide focal point for establishing functional strategies and governance over financials and staffing.
• Accountable for communication between service area functional area, RHM, and Regions leader.

Operational Delivery

• Responsible for measuring and reporting KPIs/metrics and value delivery
  Providing advice, guidance, and leadership for the colleague life cycle

Maintains a Working Knowledge of applicable federal, state & local laws / regulations, Trinity Health Integrity & Compliance Program & Code of Conduct, as well as other policies, procedures & guidelines in order to ensure adherence in a manner that reflects honest, ethical & professional behavior & safe work practices.

Functional Role (not inclusive of titles or advancement career progression)

Position reports and aligns to the Director Clinical Eng Regulatory & Quality Operations to provide functional support for national shared services.  Provides support to THCE system level services, field operations, and cross-functional departments to achieve goals and priorities.  Supports all THCE national and ministry level CE leads to enable operational effectiveness. 

Responsible for working with National Director and CE leadership team to maintain, define, track, and implement quality processes and standards supporting the Trinity Health CE program. Participates in and leads quality planning, quality assurance, quality control, and continuous improvement exercises to ensure adherence to established protocols. Develops and supports national level standards, guidelines, processes, and strategies to address internal/external business and regulatory requirements.  Provides functional analysis expertise related to tracking and monitoring established performance measures and operational standards.  Stays current with industry developments, standards, and regulatory requirements and advises National Director of emerging and evolving changes.  Identifies, defines, and advises leadership of potential issues that may impact the management and direction of the program while collaborating with all sub-departments within THCE to ensure consistency and alignment with established standards and processes. 

Responsible for monitoring and supporting repetitive ongoing operational processes such as annual Program Quality Evaluations (PQE) and alert recall management, to ensure timeliness of task completions and on time compliance metrics are met.  Participates in CE operations leadership huddles and work sessions to support all internal THCE departments to establish, document, and update all THCE Standards, Guidelines, Work Instructions, Tagging Conventions, and Numbered Memos to ensure consistency in processes across all THCE.

Supports National Director and Area Directors with transition of new service region member acquisitions and divestitures of existing member sites.  Participates in and monitors transition/divestiture projects and communicates status of transition/divestiture potential milestone barriers that could delay timely completion of established transition.

Provide research and interpretation of program compliance with local, state, and federal regulations, as well as with The Joint Commission (TJC) Environment of Care (EOC), Det Norske Veritas (DNV), National Fire Protection Association (NFPA), the College of American Pathologists (CAP), the Association of the Advancement of Medical Instrumentation (AAMI), Cybersecurity and Infrastructure Security Agency (CISA), Homeland Security, and other related standards and regulatory agencies.  Maintain awareness of new industry developments and standards. 

Minimum Qualifications

• Associate degree or equivalent in relevant field, such as business administration, management, or a related discipline.
• Five (5) to Ten (10) years of progressive experience in healthcare technology management or similar industry.
• Proven track record of successfully leading and managing a team of professionals with ability to motivate and inspire team members to achieve high performance.
• Ability to effectively manage multiple projects and priorities.
• Strong strategic thinking and problem-solving skills.
• Excellent communication and interpersonal skills.
• Knowledge of relevant industry regulations, standards, and practices

Additional Qualifications (nice to have) 

Six Sigma Blackbelt

Physical & Mental Requirements & Working Conditions (General Summary)

Direct Healthcare Services / Indirect Healthcare / Support Services:

• Exposure to conditions which may be considered unpleasant to sight, touch, sound & / or smell. Occasional
• Exposure to fumes, odors, dusts, mists & gases, biohazards / hazards (mechanical, electrical, burns, chemicals, radiation, sharp objects, etc.).      Occasional
• Exposure to or subject to noise, infectious waste, diseases & conditions.     Occasional
• Exposure to interruptions, shifting priorities & stressful situations.      Frequent
• Ability to follow tasks through to completion, understand & relate to complex ideas / concepts, remember multiple tasks & regimens over long periods of time & work on concurrent tasks / projects.     Frequent
• Ability to read small print, hear sounds & voice / speech patterns, give / receive instructions & other verbal communications (in-person & / or over the phone / computer / device / equipment assigned) with some background noise.     Frequent
• Perform manual dexterity activities & / or grasping / handling.     Frequent
• Ability to climb, kneel, crouch & / or operate foot controls.     Occasional
• Use a computer / other technology.     Frequent
• Sit with the ability to vary / adjust physical position or activity.     Frequent
• Maintain a safe working environment & use available personal protective equipment (PPE).     Continuous
• Comply with Trinity Health’s Code of Conduct, policies, procedures & guidelines.     Continuous
• Ability to provide assistance in the event of an emergency. Occasional

Direct Healthcare Services:

• Perform activities that require standing / walking with the ability to vary / adjust physical position or activity.     Frequent
• Lift a maximum of 30 pounds unassisted.     Occasional
• Use upper & lower extremities, engage in bending / stooping / reaching & pushing / pulling.     Occasional
• Work indoors (subject to travel requirements) under temperature-controlled & well-lit conditions. Continuous
• Encounter worksites (e.g., patient homes) or travel to worksites that may have variable internal & external environmental conditions.     Continuous
• Perform work that involves physical efforts (e.g., transporting, moving, positioning & / or ambulating patients).     Occasional

Indirect Healthcare / Support Services:

• Perform activities that require standing / walking with the ability to vary / adjust physical position or activity.     Frequent
• Lift a maximum of 30 pounds unassisted.     Occasional
• Experience of long periods of walking / standing / stooping / bending / pulling & / or pushing.   Occasional
• Encounter a clinical / patient facing / hands on interactive work environment.     Occasional
• Work indoors (subject to travel requirements) under temperature-controlled & well-lit conditions.     Continuous
• Work outdoors with variable external environmental conditions.      Occasional

Average Workday Activity: Occasional - O (1% - 33%), Frequent - F (34% - 66%), Continuous - C (67% - 100%)

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.