Versiti Blood Center of Indiana ยท 1 day ago
Senior Professional Quality Compliance
Grand Rapids, MI
Full-time
Onsite
Mid, Senior Level
4+ years expVersiti Blood Center of Indiana is a leader in transfusion medicine and healthcare services, dedicated to improving patient outcomes through quality and compliance. The Senior Professional Quality Compliance role is responsible for supporting the quality program, ensuring compliance with regulations, and leading quality improvement initiatives across the organization.
Hospital & Health Care
Responsibilities
Supports Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards
Identify and develop quality system improvements
Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities
Supports internal/external assessments as assigned and facilitates optimal communication between the department and the inspector/assessors
Reviews charts, tables, etc. to analyze quality metrics. Identifies areas requiring action based on quality metrics. Communicates and works collaboratively with service lines to develop appropriate actions
May review and approve standard operating procedures, validation plans and results, corrective action plans associated with events, and other required documents for compliance as required
May review regulatory and standards changes/updates for impact on existing processes. Communicates changes/updates to service line management
May develop, compile, and submit regulatory submissions as required
May review, analyze, approve, and monitor events logged in event management system, including adequacy of investigation, quality of documentation, and appropriateness of corrective and preventative actions
Reviews events to assess impact to products/test results
Perform internal audits per the approved Internal Audit Schedule, and lead a team of quality auditors, when needed
Evaluate production processes for compliance with quality requirements
Support audit team in developing audit reports; present audit reports to top management, as needed
Perform tracking and trending of data for the quality management system elements
Participate in the compilation of Quality Management Review
Conduct problem surveillance (event reports, audit deficiencies, customer complaints, supplier recalls, etc.) and work with customers to effectively resolve problems
Support and/or lead organizational projects from a quality perspective and complete assigned tasks in a timely manner
Ensure applicable service lines comply with the requirements of the quality management system, as applicable
Serve as back up support to the Supervisor, Quality Compliance, and other Quality Compliance Specialists
Participate and/or lead training, continuous improvement activities and Lean initiatives
Support external audits, as applicable
Perform other duties as assigned by direct supervisor or Quality leadership
Performs other duties as assigned
Complies with all policies and standards
Qualification
Required
Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) required
4-6 years of experience in related field required
4-6 years of experience with a master's degree required
Advanced knowledge in quality, compliance, regulatory affairs, etc. and broad knowledge of several related disciplines within those functions
Involves the use of broad theoretical knowledge or advanced knowledge of a highly specialized field and their interrelationships
Understands the interrelationships of different disciplines, directs the application of existing principles, and guides development of new policies and ideas
Focuses on providing detailed analyses and applying results to improve business operations
Requires advanced knowledge and application of external standards and regulations that impact related disciplines
Advanced knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR)
Knowledge of using professional concepts and company policies and procedures to solve a variety of problems works on problems of moderate scope
Exercises independent judgment within defined procedures and practices normally receives general instruction
Strong communication and business acumen skills
Proficiency in Microsoft Office
Possess strong attention to detail
Personal Computer (desktop, laptop, tablet) required
General office equipment (computer, printer, fax, copy machine) required
Microsoft Suite (Word, Excel, PowerPoint) required
Quality Auditor tools and techniques required
Preferred
Master's Degree preferred
Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital preferred
Quality Certifications highly preferred (i.e., ASQ CQA, ASQ CMQ/OE, ASQ CQE) preferred
Benefits
Medical, Dental, and Vision Plans
Paid Time Off (PTO) and Holidays
Short- and Long-term disability
Life insurance
7% match dollar for dollar 401(k)
Voluntary programs
Discount programs
Others
Company
Versiti Blood Center of Indiana
Versiti Blood Center of Indiana supplies blood services, blood products and specialty services to more than 60 hospitals across the state, and collects more than 130,000 units of blood annually.
201-500 employees
H1B Sponsorship
Versiti Blood Center of Indiana has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (2)
2023 (12)
2022 (9)
2021 (4)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Dan Waxman
Executive Vice President and Chief Medical Officer
Company data provided by crunchbase