Regional QA Manager

Oneblood • Oakland Park, FL

312d

About The Position

Manages the day-to-day activities of a region/functional area(s) within the Quality Assurance Regulatory Affairs department. Facilitates the interpretation and implementation of quality and regulatory requirements to ensure compliance. Coordinates regulatory affairs activities to ensure appropriate filing and registration activities are complete. Serves as a resource person for departments in accordance with regulatory agency requirements and organizational policies and procedures. This position is open to any active, eligible QA employees and can be based in any major hub.

Requirements

• Bachelor's degree in medical technology, healthcare, chemistry, biology, biotechnology or related field from an accredited college or university.
• Five (5) or more years' experience in a related field with at least two (2) years management supervisory experience or an equivalent combination of education, certification, training, and/or experience.
• In Florida, valid and current Florida Technologist license in Immunohematology preferred.
• ASQ certification preferred.
• Knowledge of and ability to interpret and apply federal and state regulations as they relate to quality assurance and regulatory affairs.
• Ability to organize work for timely completion.
• Ability to follow complex oral and written instructions.
• Ability to communicate effectively orally and in writing.
• Ability to delegate, manage and supervise effectively.
• Ability to work with minimal supervision.
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work.
• Skill in operating office equipment.
• Basic computer knowledge including Microsoft Office applications.
• Ability to commute with personal transportation.

Responsibilities

• Manages the Quality Assurance (QA) and Regulatory Affairs operations and functional activities for a region/functional areas, ensuring efficiency of workflow and continuity of service.
• Schedules functional QA staff accordingly for shared activities.
• Ensures compliance with organization, federal, state and local regulations, AABB standards and others.
• Hosts external assessments and inspections conducted by agencies with regulatory or accreditation authority and helps prepare appropriate responses when indicated.
• Plans and maintains internal audit program.
• Facilitates and monitors change control, taking appropriate actions to ensure uninterrupted compliance and quality.
• Oversees document control providing assurance that organizational documents, forms and records are relevant, current, archived appropriately and available upon request.
• Assists with the development of validation plans for equipment, software and processes; reviewing, editing and approving protocols before use.
• Manages the error management program, ensuring reports are accurate, timely complete and filed with regulators as required.
• Mentors QA staff by providing educational events.
• Participates in or initiates process improvement activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree