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Manager Quality Management

4 months ago

Grand Rapids, United States Versiti, Inc. Full time

Overview:
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Position Summary:
**Responsibilities**:

- Core Quality Responsibilities
- Establishes and promotes a work environment that supports compliance to the Quality Policy and Quality Plan and documented quality processes and procedures.
- Provides direction, coaching, and mentoring to team personnel to achieve organizational goals.
- Support quality improvement projects identified and developed by Quality personnel.
- Fosters and sustains a culture of continuous improvement practices, including leading a team of employees in the identification and implementation into quality systems/assurance, compliance, regulatory affairs and/or education and improvement activities.
- Oversee operations of the sub-organization for which he/she/they are responsible and provides direction, when necessary.
- Leads internal/external assessments and facilitates optimal communication between the department and the investigator/inspector/assessors.
- Provides resources for the actions identified based on quality metrics.
- Identify and develop quality improvements.
- Reviews and approves standard operating procedures, validation plans and results, corrective action plans associated with audits and events, and other required documents for compliance as required.
- Champions strategies and actions identified based on quality metrics.
- Supports execution of the Quality Management System
- Specific Manager, Quality Management Systems Responsibilities
- Responsible for the development and maintenance of the Quality Management System elements for Versiti, including but not limited to document and change management, events management, records management, change control, validation
- Establishes and promotes a work environment that supports compliance to the Quality Policy and documented quality processes and procedures
- Manages the quality personnel who perform the day-to-day implementation of the QMS
- Fosters and sustains a culture of continuous improvement, including leading a team of employees in the identification and implementation of changes to systems and processes that result in operation efficiencies and improved customer outcomes
- Assists direct/in-direct reports and internal customers in interpreting Quality System and product information control procedures
- Develop goals/objectives for all assigned personnel. Monitor employees' performance against goals, provide performance feedback. Write and conduct development plans / performance appraisals
- Leads and champions the work and communication between functional departments to assist in resolving issues
- Leads quality systems improvements across the organization.
- Analyzes, tracks, and trends resulting quality data to ensure proactive response to issues that may arise with enterprise quality management software
- Develops and/or reviews documentation necessary to communicate quality policies, processes, and procedures across the organization. Assures controlled documentation is reviewed, approved, and published in accordance with the document control and change management quality systems.
- Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities.
- May support or perform internal audits, analyze processes and procedures, risk mitigation assessments, provide technical support promoting productivity improvements or cost reduction opportunities. Assess non-conformance / audit findings and lead closure of actions, as needed
- Leads and supports the integration, upgrades, decommissions, etc. of the tools required to maintain an effective quality management system
- Performs other duties as assigned
- Complies with all policies and standards

Qualifications:
**Education**
- Bachelor's Degree (BS or BA) required
- Master's Degree (MBA, MS, MA) preferred
- Degree in information technology, computer software, programming, etc. preferred

**Experience**
- 7-9 years overall; required
- 1-3 years leadership experience required
- 4-6 years 5+ years with a master’s degree; required
- 1-3 years leadership required
-