Director, Quality Assurance Globus Medical
Location: Audubon, PA
Job Code: DQADP0211
The Director of Quality Assurance will direct and manage all day-to-day activities of the company's quality management program to ensure compliance with all federal and international regulations. This individual will provide strategic direction, oversight, and smooth execution of all quality functions within the organization. This individual will be a team player and provide leadership for problem solving and facilitate continuous improvements in the Globus quality management system. This person will also be responsible for successfully leading and passing FDA and other regulatory bodies audits and inspections.
Specific Duties and Responsibilities
- Provide overall leadership for quality group, set vision and formulate strategy for execution
- Oversee the following specific areas: Quality Manual/Procedures, 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, and Risk Management
- Review regulatory compliance requirements for changes affecting device manufacturing in global markets including GMPs, GLPs, European Community Medical Device Directive, ISO 9001, ISO 13485 and 21 CFR Part 820 standards and regulations.
- Oversee the adherence to company quality metrics and targets and accurately report on trends and ratings related to quality systems at the facility with regard to state, federal, local and company regulatory requirements to executive management
- Responsible for organizing and maintaining all documentation regarding regulatory compliance and FDA requirements
- Oversee the administration of the product complaint investigation process to ensure effective corrective and preventive actions are taken.
- Assist VP in setting QA compliance objectives and ensuring that targets are achieved;
- Assist VP in the Document Control Activities
- Maintaining awareness of the business context and company profitability, including budgetary control issues
- Identifying relevant quality-related training needs; ensure employees are trained to do their work and their training is documented;
- 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 as required
- Establish and support a work environment of continuous improvement that supports Globus Medical's Quality Policy
Education & Qualifications
- Minimum BS degree or equivalent in Science or Engineering. A relevant post-graduate qualification would be an advantage but not essential.
- Ability to interpret FDA, AATB, ISO, EU and other regulatory guidelines/legislation.
- Minimum 5 years experience in Quality Assurance / Quality Systems.
- Minimum of 5 years experience in the medical device industry.
- Minimum of 3 years in a management or supervisory position within a medical device company.
- Experience in successfully overseeing and managing FDA and CE notified body inspections
- ASQ Certification or equivalent formal training and experience in required.
- Demonstrated knowledge and understanding of the Quality System Regulations (FDA), ISO 13485:2003 requirements and other related regulations with emphasis in CAPA Systems
- Extensive experience in the medical device/tissue industry to include Production QA/QC experience; experience working with clean rooms, sterile processing, sterilization dose audits required.
- Extensive experience in Process (manufacturing; sterilization etc.) Validations required.
- Presentation skills and ability to train personnel in quality matters.
||Valley Forge Business Center |
2560 General Armistead Avenue
Audubon, PA 19403