ISO Coord and Lead Internal Auditor

York, PA | Professional | Tracking Code: 57446

Position Summary:

General Summary:
Under the general supervision of the Director-Quality, Regulatory Compliance & Patient Safety (WSRH), supports and coordinates the Hospital-wide safety program and ISO 9001 compliance. Promotes and maintains a Hospital-wide environment of safe care for patients treated at the Hospital. Collaborates with appropriate organizational leaders in coordination for Det Norske Veritas Germanischer Lloyd, Commission on Accreditation of Rehabilitation Facilities and Department of Health survey preparation at WellSpan Surgery and Rehabilitation Hospital.

Duties and Responsibilities:

1 Responsible for the facility Safety program and serves as the Chair of the Safety Committee.
2 Conducts risk assessments and identifies controls in place to mitigate identified risks.
3 Conducts safety, quality and environmental system compliance audits.
4 Maintains the ISO 9001:2015 quality system. Ensures compliance with the ISO 9001:2015 standards.
5 Administers the Internal Audit and Document Control processes for the Quality Management System.
6 Ensures all processes needed for the quality management system are established and maintained.
7 Provides training to the organization on ISO 9001 requirements and the Quality Management System.
8 Collaborates with the Director to ensure ongoing coordination and compliance with appropriate accreditation standards and Department of Health regulations. Keeps abreast of appropriate regulatory agency requirements and communicates changes to the appropriate WellSpan entity.
9 Uses various databases to compile, track, analyze and report data and prepares regularly scheduled or special reports.
10 Serves as the back-up for the Director.



Required Skills

Minimum Education             Bachelor's Degree

Minimum Experience           3 - 5 years working with ISO 9001 standards working in the Quality, Regulatory Compliance field.

Preferred Experience           Experience with regulatory standards

Pref Cert/Registration          Certification as an ISO 9001 Lead Auditor


Required Experience
  • Occasionally subjected to irregular hours
  • Must be proficient with the ISO 9001 quality management system
  • Knowledge of theory and process of performance improvement, facilitation, project management and data analysis skills a plus
  • Excellent communicator with problem solving skills; must be flexible and able to function under pressure; organizational skills, independent thinking and management competencies
  • Knowledge of regulatory standards, both national and state is an advantage. Demonstrated experience in preparing for and handling state and federal surveys would be an advantage

Quality of Life

WellSpan Health is an integrated health system that serves the communities of central Pennsylvania and northern Maryland. The organization is comprised of a multispecialty medical group of more than 1,500 physicians and advanced practice clinicians, a regional behavioral health organization, a home care organization, eight respected hospitals, more than 19,000 employees, and 170 patient care locations. WellSpan is a charitable, mission-driven organization, committed to exceptional care for all, lifelong wellness and healthy communities. We are committed to transforming the health of the communities we serve and to educating the next generation of clinicians, staff and leaders.

Quality of Life
Quality of Life

Founded in 1741, the city of York is considered by many as the first capital of the United States. The Articles of Confederation were signed by the Second Continental Congress here in 1777. Its beautifully restored historic district is an architectural treasure. While York retains its farming and manufacturing heritage, at its heart York is a thriving cultural community that has attracted creative talent and innovative entrepreneurial investors from across the nation.

Life in York County offers affordable housing, options for higher education, a thriving arts and cultural community, historical attractions, parks and recreational resources, semi-professional baseball team, fine dining and more — within an easy drive of major East Coast cities.

York County residents can find local employment in healthcare, manufacturing, technology, agricultural and service sectors. (Patient population: 445,000)

Equal Opportunity Employment

WellSpan Health is an equal opportunity employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color or any other protected class. WellSpan Health does, however, have a tobacco-free/nicotine-free hiring policy.

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