Manager, Quality

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives.

Under the direction of the Executive Director, Program Operations, the Manager of Quality, is responsible for the development, implementation, and administration of the quality management program of the Beth Israel Lahey Health (BILH) Healthcare Technology Management (HTM) and Clinical Engineering (CE) department. This individual will play a critical role in ensuring adherence to quality standards, implementing quality improvement strategies, compliance with regulatory requirements, driving continuous improvement initiatives, providing oversight of the medical equipment recall and incident investigation processes, and oversees the staff competency program.

Job Description:

Essential Duties & Responsibilities including but not limited to: 
1.    Responsible for implementing processes and organizational structures that commensurate with an operation of this size and conducting business in accordance with the BILH mission, vision, and strategic objectives. (essential) 
2.    Ensures that the quality program and service operations are conducted in compliance with applicable accreditation, statutory and regulatory requirements, including the Joint Commission, DNV, and ISO requirements where applicable. (essential)
3.    Develops high-impact goals, decisions, and strategies that promote improvements, program development, and operational enhancements centered on compliance with industry quality standards and regulatory agencies. (essential)
4.    Develops and implements quality management systems and strategies in accordance with ISO 13485 and other relevant HTM industry standards to ensure compliance and alignment with regulatory requirements. (essential)
5.    Establishes and maintains quality control processes, procedures, and documentation to monitor and evaluate the performance and reliability of healthcare technology systems and equipment.
6.    Develops and implements a department-wide training and competency program including educational materials, procedures, metrics, and competencies for medical technologies (essential)
7.    Manages medical device incident investigation process, which includes overseeing and monitoring hospital and department safety reporting systems to capture sentinel events, near misses and areas for improvement related to medical equipment, assigning root cause analysis follow-up to technical staff, developing QI initiatives, and reporting medical device related events to the Food and Drug Administration. (essential)
8.    Oversees biomedical equipment hazard alert and recall process, engaging with stakeholders in risk management, healthcare quality, and clinical departments when appropriate. (essential)
9.    Communicates effectively and builds a trusting partnership with organizational leadership, medical staff, nursing, and other colleagues to ensure staff inclusion and participation in the pursuit of the highest quality service to our customers.
10.    Participates in system-level steering committees and collaborates with clinical engineering, supply chain, radiology, clinical laboratory, information systems, senior administration, physicians, and nursing leadership at each BILH entity. 

Minimum Qualifications: 
Education:    Bachelor's degree in Engineering required. Master's degree in related fields preferred.

Licensure, Certification & Registration:    Certification as a CBET, CHTM, PMP, CCE, PE, or other engineering-related certification is preferred. Certification in Lean Six Sigma (Green Belt or above) is preferred.

Experience:    10 years of relevant management experience. A track record of success in developing successful strategic plans. Demonstrated success in leading initiatives that have an impact across the organization. Progressively expanding scope and responsibility and management-level experience in a dynamic healthcare system. Experience with ISO 9001, ISO 13485 or other quality management systems preferred.

Skills, Knowledge & Abilities:    Must possess a strong knowledge of technology and engineering with a thorough knowledge of Healthcare Technology Management, Clinical Engineering, and Diagnostic Imaging business operations typically attained by achieving a Master’s degree in Engineering, Healthcare Administration, Business, or a related field. 

Preferred Qualifications & Skills:
Advanced interpersonal skills coupled with excellent presentation, communication, budgetary, analytical, collaboration, and group facilitation skills essential for effectively representing BILH internally and externally.  Dept./Unit-Specific Skills:      Ability to establish and maintain effective working relationships throughout B