Description
POSITION DESCRIPTION:Manage the division's internal and external audit functions to ensure compliance to regulatory and statutory requirements. Coordinate activities of Third Party visits (Notified Body, FDA). Coordinate Management Review Activities. Ensure overall QMS system compliance with applicable regulatory and statutory requirements.
Responsible to lead and manage a group of Quality professionals to ensure a high level of Quality Management System and regulatory compliance in the plant. This position will be responsible for Quality Management System development and implementation, coordinating Management Review, coordinating third party audits (FDA, ISO, etc) and management of the internal audit, CAPA, complaint and document control functions.
- Ensure overall QMS system compliance with applicable regulatory and statutory requirements.
- Perform internal quality assurance audits to 21CFR 820, ISO 9001:2000, ISO 13485:2003, 93/42/EEC and other applicable Standards to ensure corporate and regulatory compliance.
- Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformity cited during audits.
- Develop and conduct effective training programs on related QA topics.
EDUCATION/EXPERIENCE:
- Bachelor's Degree in scientific or other relevant field
- 5+ years experience managing a team.
- Demonstrated ability to effectively lead cross-functional/cross-plant project teams using relevant project management tools such as Microsoft Project.
- Demonstrated experience in developing quality management systems; design and development of training programs/courses; lean documentation; and Six Sigma methodology.
- Demonstrated auditing experience in medical device or other regulated manufacturing environment (biotech, pharma, military/space).
- Applied understanding of CGMPs, ISO 9001, ISO 13485, and CMDR.
- Demonstrated ability to effectively advocate a strategic quality systems approach and lead the organization to compliance.
- Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.
To find out more about Real please visit www.realstaffing.com