Manager I, Quality

VIZIA Diagnostics, formerly Boston Scientific Pathology, is seeking a Manager I, Quality for their Alpharetta, GA Laboratory.

About Us

VIZIA Diagnostics is a stand-alone, surgical pathology laboratory serving clients nationwide. VIZIA delivers best-in-class service excellence in diagnostic patient care.

Today, VIZIA is a subspecialty model dedicated primarily to the practice of gastrointestinal pathology with GI subspecialty-trained and experienced pathologists and histotechnicians focused exclusively on GI specimens to ensure the highest level of quality. VIZIA is a growing company with potential advancement into other surgical pathology specialties, including a more robust genitourinary practice.

We are seeking an experienced Quality Manager who can develop, establish, and maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of patient care adheres to regulatory agencies to ensure lasting customer satisfaction. Reviews, analyzes, and reports on quality discrepancies related to patient care, functional systems and develops corrective actions for recurring discrepancies. May serve as liaison between the company and the various governmental agencies. Collaborate with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications of regulatory bodies.

Scope:

Accomplishes results through lower-level subordinate supervisors or through experienced professional employees who exercise significant latitude and independence in their assignments. Monitors progress toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility. Receives assignments in the form of objectives with goals. Provides direction to employees according to established policies and management guidance. Often heads a centralized functional activity.

Key Responsibilities:

• Ensures compliance and ongoing accreditation with applicable regulatory agencies (CAP, CLIA, OSHA, HIPAA, JCAHO, CLEP, ISO).
• Manages gap analysis, internal audits, and external inspections for any applicable regulatory agencies (CAP, CLIA, OSHA, HIPAA, JCAHO, CLEP, ISO).
• Plans and implements standards for laboratory policies and practices in compliance with patient care protocols, laws, and regulations.
• Participates in the development and maintenance of a company culture characterized by highly motivated employees with clear understanding of their roles, a willingness to embrace quality issues and a strong focus on customer satisfaction and patient care.
• Develops metrics that foster continual quality improvement and customer satisfaction as part of an overall Quality Management System.
• Owns leadership of and facilitates the collection of data for Quality Management Review Meetings.
• Identify best quality practices and areas for improvement and lead continuous improvement projects across the business.
• Manage document control process, ensuring all procedures receive appropriate approval and the necessary employees training.
• Works in close collaboration with clients and sales team to reduce external defects.
• Works in close collaboration with laboratory team to reduce internal defects.
• Initiate, investigate, and disposition NCEs and CAPAs. Trend, identify, prioritize, resolve and report quality issues using information gained from testing and other process monitoring activities, Non-Conforming Events (NCEs) and Corrective and Preventative Actions (CAPAs), customer complaints, continuous improvement projects and other quality metrics.
• Maintains effective communications with leadership administrative staff, commercial team, and all levels of lab employees.
• Other duties as assigned.
• The Vizia Diagnostics Pathology Laboratory attests to the following: For HIPAA compliance purposes, this position has been reviewed by management and meets the ‘need to know’ PHI access criteria of the HIPAA Security Rule. Additionally, per the HIPAA Privacy Rule, the minimum necessary PHI data elements 2 have been identified by management and the minimum necessary PHI access has been granted to the employee/contractor for them to satisfactorily execute the role and responsibilities of this position.

Education/Experience Requirements

• Bachelor's degree or 4 years university degree completed in laboratory management, preferably in a regulatory or compliance.
• Experience working with Quality Management including strong knowledge of all laws and regulations that are required by CLIA, CAP, OSHA, ISO, CLEP, and other related legislative and/or state health departments and organizations.
• Experience in managing laboratory resources, including equipment, materials, and personnel.
• Excellent professional communication skills, including verbal, written, and presentation, with a knowledge of Microsoft Office

Management Requirements:

• May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements)

Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the Vizia Diagnostics Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Alpharetta, GA 30009: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

Salary : $59,700 - $75,500