The Quality Assurance Manager oversees the Quality Assurance department. They are responsible for ensuring PTT processes and systems comply with applicable regulations including 21 CFR 1271, 820, 210/211 and AATB requirements. He/she is responsible for the overall oversight and execution of the Quality Assurance Program initiatives, ensuring regulatory and accreditation compliance as it relates to organizational goals, objectives, and work processes. The QA Manager reviews and analyzes data to determine where improvement is needed within the quality systems and assists with regulatory audits and customer requests as needed.
Key Interactions and Relationships
Regular communication with the Director of RA/QA to ensure all goals for the Quality Assurance Department are outlined, and executed accordingly to meet quality commitments
Daily communication with team members in the Quality Assurance department to ensure goals and objectives are executed in a timely manner
Essential Duties and Responsibilities
Demonstrates a commitment to the development, implementation and effectiveness of PTT’s Quality Management System per ISO, FDA and other regulatory agencies.
Maintain current knowledge of and comply with FDA, AATB, OSHA, cGTP, and federal and local government regulations at all times.
Review QSM procedures, policies, and forms to ensure compliance with regulatory and accreditation/licensing requirements.
Coordinate department planning to ensure that the QA Department functions optimally within the scope of the PTT Quality Policy.
Host and participate in all vendor and regulatory body audits off PTT as well as managing any required corrective actions.
Ensure that the QA Department interfaces with key functional groups (NPD, Manufacturing, Customer Service, and Quality Control) to drive company-wide or cross-departmental quality improvement initiatives.
Perform final review and approval of non-conformances, deviation incidents, corrective actions, customer complaints, and PTT SOPs.
Train associates in quality and compliance procedures; interpret company policies and procedures for associates.
Maintain quality reports, statistical reviews and relevant documentation.
Facilitate proactive solutions by collecting and analyzing quality data.
Prepare data for management review.
Maintain open, regular communication with appropriate personnel concerning quality and/or regulatory issues.
Manage and/or perform special projects to support continuous improvement companywide.
Maintain and advance technical skills through professional education and training to advance the effectiveness of Regulatory and Quality Systems.
Supervise, lead and delegate work to Quality Assurance Associates, keeping the Director of RA/QA informed of work progress.
Train associates in work and safety procedures; interpret company policies and procedures for associates.
Evaluate individual performance and provide mentoring and discipline to direct reports.
Interview job applicants and recommend hiring new associates.
Keep records of associates' attendance and hours worked.
Other duties as assigned by Supervisor and or PTT Leadership.
Knowledge, Skills, and Abilities Required
Law and Government — Knowledge of the Codes of Federal Regulations applicable to operations performed by PTT
Administration and Management — Knowledge of business and management principles involved in planning, leadership techniques, project management and coordination of people and resources.
English Language — Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
Systems Analysis — Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
Quality Control Analysis — Knowledge of methods for conducting tests and inspections of products, services, or processes to evaluate quality or performance.
Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Active Listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
Oral and Written Communications — Conveying information and ideas so others will understand.
Physical Environment & Working Conditions
Full Time position (40 hours or more) based in Arizona. Hours may include evenings and weekends to perform tasks outlined in the job description.
The Quality Assurance Manager may work in a clean room environment where protective clothing such as hoods, face masks, gloves, boots, and coveralls are required.
Equipment & Machines Used
Desktop computer and general office equipment.
The Quality Assurance Manager is expected to maintain confidentiality of all donor/recipient information.
Education and Work Experience Requirements
Bachelor’s degree in engineering, bioscience, or related field is required
5+ years’ experience managing a Quality Assurance program in a related FDA or AATB regulated industry
Knowledge of tissue-banking regulations, FDA regulations is required; AATB standards is preferred
Must become or be will wiling to become Certified Tissue Banking Specialist with 2 years
ASQ (CQA or CBA) or related certification preferred
Internal Number: 001
About Pinnacle Transplant Technologies
Founded in 2010, Pinnacle Transplant Technologies (PTT) recognized the need to establish a processing and distribution facility that would enable medical professionals to acquire safe quality allograft tissue for transplant. The company manufactures innovative allografts produced to the highest standards of quality and safety. With a dedication to customer service, we are devoted to being the most responsive and accommodating Tissue Bank in the industry. Learn more about our specific products.
Pinnacle Transplant Technologies is a multi-service tissue bank dedicated to the ethical participation in the Donate Life ™ process. U.S. Food and Drug Administration (FDA) registered and American Association of Tissue Banks (AATB) accredited, Pinnacle only works with federally chartered Organ Procurement Organizations (OPOs) and agencies accredited by AATB to help provide superior allografts for transplantation, assure transplant patient safety, safeguard our associates, and assure reverence to our donor families.