Job Details

• Core Quality Responsibilities * Assists Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards. * Assists Manager in identifying quality system improvements. * Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities. * Supports internal/external assessments as assigned. * Prioritize tasks to meet the needs of assigned quality objectives. * May prepares charts, tables, etc. to analyze quality metrics. * Review, analyze, approve, and monitor events logged in event management system.
• Specific External Quality Coordinator Responsibilities * Provide support to the supplier quality and contract function(s) with a focus on supplier/ customer/ service development-related projects/initiatives * Support the implementation and maintenance of the Supplier Quality Management process to ensure excellent quality of purchased goods * Initiate and resolve supplier non-conformances including root cause and corrective/preventive actions to hold suppliers accountable to Supplier Corrective Action Request (SCAR) commitments * Initiate and resolve Quality exceptions, root cause investigations, containment/corrective actions, risk-based escalation (as appropriate) * Support continuous improvement initiatives, quality system and procedure adjustments * May perform supplier audits and assess non-conformance / audit findings and participate in closure of supplier actions, as needed * May support the maintenance of the contract management process to ensure a consistent and efficient process for the initiation, negotiation, development, review, execution, documentation, monitoring and modification of contractual agreements * May reviewing incoming material from suppliers, if needed, to determine appropriate disposition
• Performs other duties as assigned
• Complies with all policies and standards

Education

• High School Diploma required
• or equivalent required
• Associate's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) preferred
• Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) preferred

Experience

• 1-3 years experience required with H.S. diploma required
• 1-3 years experience required with associates degree required
• Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred

Knowledge, Skills and Abilities

• Ability to read and interpret documents such as Standard Operating Procedures, safety rules, operating and maintenance instructions, and other department manuals required
• Must have basic mathematical aptitude such as adding and subtracting two-digit numbers and multiplication and divisions with 10’s and 100’s to be used for weight measurement, volume, distance, and money. required
• Ability to apply judgment to detailed but very structured written or oral instructions and to deal with problems involving concrete variable in standardized work procedures. required
• Able to organize work to provide productive workflow needed in component preparation. required
• Good knowledge of Quality Systems, Compliance, Supplier Quality etc. areas achieved through prior study, preferred preferred
• Applies knowledge of the principles and practices in a recognized professional field requiring academic preparation required
• Applies knowledge of standardized rules, procedures, and operations within own area required
• Performs actions based on previously established guidelines required
• Excellent oral communication skills required
• Proficiency in Microsoft Office required
• Possess strong attention to detail required
• Possess good interpersonal skills required

Licenses and Certifications

• ASQ CQA, ASQ CQT preferred

Tools and Technology

• Personal Computer (desktop, laptop, tablet) required
• General office equipment (computer, printer, fax, copy machine) required
• Microsoft Suite (Word, Excel, PowerPoint) required