at Vitalant in Rosemont, Illinois, United States
Job Description
Description
Vitalant is currently seeking a Quality Manager to be responsible for assisting in managing the review of quality systems and compliance in all areas of technical and clinical operations. This position serves as a resource to operations on quality issues, and operational excellence standards. Participates in performance improvement initiatives through data and process analysis.
All interested applicants are asked to provide a cover letter in addition to a resume.
DUTIES AND RESPONSIBILITIES:
- May assist with coordination of workflow, training, and mentoring of support staff, as required.
- Supports cultural transformation to drive enterprise strategies of Operational Excellence. Facilitates and/or leads continuous improvement initiatives to drive local, divisional or enterprise strategy incorporating Operational Excellence.
- Trains and coaches divisional operations divisional operations staff in the implementation and daily application of Lead Measures.
- Actively encourages and supports divisional use of process improvement tools and methodologies. Serves as an improvement resource to Operations. Supports process improvement in alignment with National Office driven to performance goals.
- Leads and/or participates in process mapping activities for new and revised processes.
- Participates in planning and change implementation to ensure quality at the source.
- Evaluates process changes to include pre/post implementation assessments where applicable.
- Plans, schedules and performs internal quality risk assessments to ensure critical processes are compliant
- Prepares final assessment reports and communicates outcomes to divisional management. Facilitates process improvement activities for identified observations.
- Provides divisional support to the Quality Analysis staff regarding deviation management processes. Ensures all assigned deviation management reports are accurate and timely. Conducts root cause analysis, reviews corrective actions, and ensures corrective actions are implemented and effective for the assigned deviation management event.
- Ensures requests for required regulatory licenses are submitted timely.
- Hosts external inspections occurring onsite. Supports divisional operations management hosting external inspections occurring at remote locations. Facilitates root cause analysis and ensures corrective actions are implemented and effective. Assists in development of inspection responses. Prepares risk assessment documentation related to observations for internal review.
- Participates on the divisional review team to evaluate nonconforming products, materials, or test results and assesses the impact on external customers. Ensures required actions are implemented.
- Assists in the oversight of Clinical Trial Studies.
- Provides divisional support of safety management. Performs safety observations to ensure compliance.
Requirements
Knowledge/ Education
Bachelor's degree or equivalent combination of education and experience required.
Licenses/ Certifications
Certification as a Medical Technologist or SBB preferred.
Experience
Four years related experience in a regulated industry required. To include:
Two years in a quality, regulatory, and/or auditing environment.
Six months supervisory experience preferred.
Skills/Abilities
- Must possess the skills and...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
