Job Posting #914026
Position: Manager, Quality Management and Regulatory Compliance
University Health Network (UHN) is looking for an experienced professional to fill the key role of Manager, Quality Management and Regulatory Compliance in our Biomedical Engineering Department.
Transforming lives and communities through excellence in care, discovery and learning.
The University Health Network, where “above all else the needs of patients come first”, encompasses Toronto Rehabilitation Institute, Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre and the Michener Institute of Education at UHN. The breadth of research, the complexity of the cases treated, and the magnitude of its educational enterprise has made UHN a national and international resource for patient care, research and education. With a long tradition of groundbreaking firsts and a purpose of “Transforming lives and communities through excellence in care, discovery and learning”, the University Health Network (UHN), Canada’s largest research teaching hospital, brings together over 16,000 employees, more than 1,200 physicians, 8,000+ students, and many volunteers. UHN is a caring, creative place where amazing people are amazing the world.
University Health Network (UHN) is a research hospital affiliated with the University of Toronto and a member of the Toronto Academic Health Science Network. The scope of research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. Research across UHN’s five research institutes spans the full spectrum of diseases and disciplines, including cancer, cardiovascular sciences, transplantation, neural and sensory sciences, musculoskeletal health, rehabilitation sciences, and community and population health. Find out about our purpose, values and principles here. (https://www.uhn.ca/corporate/AboutUHN/Purpose_Performance/Pages/purpose_values_principles.aspx)
The Manager, Quality Management & Regulatory Compliance plays a key role in managing University Health Network’s efforts around regulatory compliance for patient management software and systems, both internally developed and commercially procured. The primary responsibilities include: assisting and enabling the institution to comply to relevant software quality management regulations, such as ISO 13485, MDSAP, the Food and Drug Act, European Medical Device Directive, etc.; leading the institution through the ISO 13485 certification process and annual audits; developing and enforcing monitoring, recall, and notification processes; enabling compliance to policy around procurement of licensed software; performing cross-functional and other responsibilities, as required and/or requested. In addition, the Manager, Quality Management & Regulatory Compliance provides oversight and management of UHN’s process of regulatory reporting of Incidents as they relate to Vanessa’s law as well as the UHN OneRecall Alerts and Safey Notices process.
Helps to enable the Quality Management system to comply with ISO 13485, European Medical Device Directive, FDA QSRs and Canadian Medical Device Regulations. Ensures that the processes needed for the Quality Management system are established and assist with the implementation and maintenance of the processes.
Reports to top management on the performance of the Quality Management System on any need for improvement, as a Quality Management Representative; reports directly to the Executive Director of Biomedical Engineering, and will have indirect reporting lines to leadership from the following departments: UHN Digital and JDMI (The Joint Department of Medical Imaging).
Ensures the promotion and awareness of regulatory and customer requirements throughout the organization.
Assists in the identification and correction of manufacturing and post-market product quality issues including product complaint and corrective action.
Assist in engaging and/or consulting with applicable regulatory agencies as it relates to UHN’s plans for changes to currently distributed medical device products (i.e. new features and/or new jurisdictions for distribution) and, new3 medical device products planned for future development.
Ensures appropriate regulatory approvals are obtained for medical device products distributed outside of UHN.
Assists in vigilance reporting in accordance with Health Canada, US FDA, and other regulatory standards.
Assists in the implementation and ongoing management and updating of QA procedures including document control and finished product testing.
Assists in the engineering change and software control programs as related to software and processes.
Schedules and prepares necessary material, and conducts audit and certification audits, as well as with Regulatory agencies (e.g., Health Canada, etc.), and resolves any reported non-conformances.
Assumes responsibility for the amendment and enforcement of institutional software procurement and licensing terms and conditions to comply with relevant regulations.
Assists in the inventory, licensing, and compliance of relevant software developed and/or used at the institution to all relevant regulations.
Guides and assists completing the MDSAP (Medical Device single Audit Program).
Responsible for maintaining all quality management system procedures, updating to comply with regulations and changes to team processes, and ensuring appropriate communication and training of staff on changes.
Supervises and/or manages assigned operational/strategic initiatives including the Vanessa’s Law reporting process and the OneRecall Alerts and Safety Notices process.
Provides leadership and oversight to the Quality & Compliance Specialist, who is responsible for reporting UHN incidents that meet Health Canada’s mandatory Vanessa’s Law reporting requirement and managing the implementation and maintenance of the UHN OneRecall Alerts and Safety notice system.
Provides leadership and direction to team members in the development of technology deliverables; acts a lead and represent team for any UHN Digital partner sites.
Acts as Administrative lead for assigned team members.
Responsible for guiding and regular communicating to the internal project teams on evolving processes and changes in procedures
Establishes the boundaries within which the team has freedom to operate.
Develops, implements and communicates performance measures
Coaches and motivates team members to achieve objectives; provides on-going coaching and feedback, in a timely and objective manner.
Co-ordinates the selection and new hire interviews, as applicable
Champions and supports the integrated culture of the quality management system within the internal team.
Invites different perspectives from roles inside and outside of the team
Resolves conflicts and provides resolution to team to ensure matters are resolved, in a fair manner.
Delegates appropriate and challenging work to team members.
Promotes and facilitates opportunities for the professional growth/development of team members, recommending training/development programs that improve performance.
Allocates team resources including: monitoring, assigning and coordinating team workloads
Ensures standard operating procedure documentation/record-keeping is complete and up-to-date.
Maintains strong relationship with customers of the applications, including clinical and non-clinical staff.
Documents, reviews and updates operational and technical information.
Works with and within the standards and processes outlined by Digital Enterprise Architecture team.
Works within UHN Digital Enterprise Architecture standards, consults and collaborates with the Enterprise Architecture team ensuring all standards are met.
Acts as an Ambassador for various Organizational Committees and Project Teams.
Represents UHN in a professional manner with internal and external stakeholders.
Fulfills the role of key contributor to organizational improvement initiatives, to revise/refine policies, processes and/r tools.
Recognized for cross-disciplinary expertise
Acts as and is sought as a key resource for providing resolution of unique and highly complex business problems by providing sound and viable solutions that will achieve quality that satisfies the organizational goals and objectives.
Maintains expert in corroborating and collaborating to build consensus among the diverse perspective.
Maintains active member and act as an Ambassador in Organizational Committees and Project Teams including the following: RSAC; COC; eHR CAC; SMP; Ambulatory eHR Sub Committee (AeCS); CBPIT; Clinical Content Committee; Digital LPSC; Joint Health and Safety Committee.
Works in compliance of the Occupational Health & Safety Act and its regulations, reporting hazards, deficiencies and contravention’s of the Act, in a timely manner.
Leadership: Supervising & Developing People
How many employees/students received direction from this job: 10 plus employees.
The primary leadership functions of the role: provides orientation; prioritizes/monitors work; communicates assignments; provides information for PES; acts as a resource/role model; identifies training requirements; coaches/influences/encourages; provides work guidance/advice; facilitates and resolves problems; make recommendation on quantity/quality of work; show other how to perform certain work procedures.
At minimum, completion of a bachelor’s degree in Computer Science, Health Informatics or recognized equivalent required.
Excellent process analysis and application skills.
Excellent analytical and problem-solving skills with the ability to systematically analyze situations/issues, identify options, draw logical conclusions, and determine/recommend practical courses of action.
Excellent verbal and written communication skills.
Very good interpersonal skills.
Able to work with minimal supervision on simple to moderately complex tasks
Able to work with multidisciplinary teams in a positive and productive manner
Ability to effectively deal with high-priority unscheduled tasks and problems.
Familiarity with local area networks and interfacing/integration with other computers.
Familiarity with programming techniques and languages.
Understands basic Internet and client/server architectures.
Understands how to interpret customer business needs and translate them into application and operational requirements.
Understands how various issues affect each other and the outcome of projects.
Understanding of database management.
Possesses working knowledge of programming/scripting, SQL, database design, and/or HL7 Interfaces, ITIL.
In depth knowledge of application architecture and development
Self-motivated team player who can work independently.
At minimum, over 4 years up to and including 6 years practical and related experience and/or 2 years on the job training required.
Two years of related experience in software design and development, including SLDC (software development lifecycle) and working closely with software teams.
Over four years of practical and related experience of quality systems: change control, CAPA and document control.
At least two years of direct experience as a Quality Manager.
Project Management/Business Analysis experience, especially within software development.
Regulatory Submissions filling experience, an asset (e.g. Health Canada/FDA etc.).
Solid experience with meeting facilitation and presentation development and delivery.
Expert in developing and presenting to various stakeholder groups including senior management.
Background in healthcare is a requirement.
Thorough knowledge of medical device and regulatory requirements including ISO 13485 and ISO 14971 and the Canadian Medical Device regulation.
Vaccines (COVID-19 and others) are a requirement of the job unless you have an exemption on a medical ground pursuant to the Ontario Human Rights Code.
If you are interested in making your contribution at UHN, please apply on-line. You will be asked to copy and paste as well as attach your resume and covering letter. You will also be required to complete some initial screening questions.
Posting Date: February 7, 2023 Closing Date: March 7, 2023
For current UHN employees, only those who have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN’s attendance management program, and possess all the required experience and qualifications should apply.
UHN thanks all applicants, however, only those selected for an interview will be contacted.
UHN is a respectful, caring, and inclusive workplace. We are committed to championing accessibility, diversity and equal opportunity and welcomes all applicants including but not limited to: all religions and ethnicities, LGBTQ2s+, BIPOC, persons with disabilities and all others who may contribute to the further diversification of ideas. Requests for accommodation can be made at any stage of the recruitment process providing the applicant has met the Bona-fide requirements for the open position. Applicants need to make their requirements known when contacted.
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