Director of Quality
Bone Bank Allografts is the distributor of the SteriGraft® line of high-quality bone and soft tissue allografts to medical professionals. BBA became a part of Globus Medical in 2014 and has continued to help doctors and their patients with over 1 million successful transplantations. Join us!
The Director of Quality Assurance directs and manages all day to day activities of BoneBank Allografts’ quality management programs to ensure compliance with all federal and international regulations. The Director of QA provides strategic direction, oversight, and smooth execution of leadership for problem solving, facilitates continuous improvements in the Bone Bank Allografts system and is responsible for leading and passing FDA and other regulatory body’s audits and inspections.
The responsibilities of the position include, but are not limited to, the following:
- Providing leadership for the Quality and Product Development groups, contribute to the shared vision for the success of the facility, and help formulate a strategy for execution of assigned goals and objectives
- Overseeing the following specific areas: Quality Manual/Procedures, Document Control, Management Review, Corrective and Preventive Actions (CAPA), Complaint Handling, Supplier Quality Program, Tissue Banking, Quality Control, Document/Records Management, Training, Lot Release/Distribution Control, Recall Management, Process Validation, Design Control, Risk Management and International Regulatory program maintenance
- Reviewing regulatory compliance requirements for changes affecting tissue manufacturing in global markets including GTP’s, GMP’s, AATB Standards 21 CFR Part 1271, GLP’s, European Community Medical Device Directive, ISO 9001, ISO 13485, 21 CFR Part 820 standards and regulations
- Overseeing the adherence to company quality metrics and targets and accurately reporting on trends and ratings related to quality systems at the facility with regard to state, federal, local and company regulatory requirements to executive management
- Organizing and maintaining all documentation regarding regulatory compliance and FDA requirements
- Administering the product complaint investigation process to ensure effective corrective and preventive actions are taken
- Supporting the (Corporate) Director of Quality Assurance in setting QA compliance objectives for Bone Bank Allografts and ensuring that targets are achieved. Rejecting product or discontinuing process or release when warranted to ensure the quality and safety of the allografts produced
- Maintaining awareness of the business context and company profitability, including budgetary control issues
- Identifying relevant quality-related training needs; ensur employees are trained to do their work and their training is documented and effective
- Ensuring procedures are properly understood, carried out and evaluated
- Working together with staff of different disciplines to plan, formulate and agree on new and improved quality procedures or products as required
- Establishing and implementing a work environment of continuous improvement that supports Bone Bank Allografts Quality Policy
- Aiding the (Corporate) Director of Regulatory Affairs with the coordination of BBA Domestic and International Registrations, Licenses, Accreditations
- Assisting the (Corporate) VP Legal with the review, approval and maintenance of company contracts on-site
- Providing written and oral communication to help ensure an engaged and informed workforce and management team and keep them informed of results
- Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Representing the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
In order to be qualified for this role, you must possess the following:
- Bachelor’s degree or equivalent in Science or Engineering; may consider direct experience for education requirement
- AATB Certified Tissue Bank Specialist Certification required; ASQ Certification or equivalent formal quality training and experience preferred
- Ability to interpret FDA, AATB, ISO, EU and other regulatory guidelines/legislation
- 5+ years’ experience in Quality Assurance/Quality Systems
- 3+ years in a management or supervisory position within a tissue banking company
- Skilled in successfully overseeing and managing FDA and AATB notified body inspections
- Proficient in the tissue banking industry including Production QA/QC, clean rooms, sterile processing, and sterilization dose audits
- Comprehensive experience in Process Validations including Manufacturing and Sterilization
- Knowledge and understanding of the Quality System Regulations (FDA), AATB Standards requirements and other related regulations with emphasis in CAPA Systems
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 60 pounds and occasionally lift and/or move up to 70 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.