Quality Assurance Program Manager - OneBlood

Facilitates the interpretation and implementation and compliance of quality and regulatory requirements, including medical devices. 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.

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

• Ensures compliance with organization, federal, state and local regulations and AABB standards
• Coordinates regulatory affairs activities to ensure appropriate filing and registration activities are complete
• Monitors quality control results and reports for completion; identifying issues requiring corrective action and facilitates development of action plans to address quality control failures
• Hosts external assessments and inspections conducted by agencies with regulatory or accreditation authority
• Maintains internal audit program to include root cause analysis, corrective and preventative action
• Facilitates and monitors change control, taking appropriate actions to ensure uninterrupted compliance and quality
• Oversees document control system and ensures organization documents, forms and records are relevant, current and archived appropriately
• Assists with the development of validation plans for equipment, software, including medical devices, and processes; reviewing, editing and approving protocols before use
• Ensures error management program is compliant including investigation, corrective and preventive action and follow

To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION AND/OR EXPERIENCE:

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 or an equivalent combination of education, certification, training, and/or experience.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

Valid and current Florida Technologist license in Immunohematology preferred. ASQ certification preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

• 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 travel 20% of the time
• Ability to commute with personal transportation.

PHYSICAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds).

ENVIRONMENTAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. 

Functions are regularly performed inside without potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances.  The noise level in the work environment is usually moderate.

OneBlood is an Equal Opportunity Employer/Vet/Disability/Other Protected Categories