Hanger, Inc. is looking for a quality/compliance, regulatory affairs specialist and inspector to maintain and improve their Quality Management System to meet National and International laws and regulations and pertinent quality standards.
Requirements
- Lead auditor training required
- Lean / Six Sigma training preferred
- Master Control knowledge a plus
- Digital QMS knowledge a plus
- Familiarity with QA inspection tools.
Responsibilities
- Responsible for maintaining and improving the Quality Management System to meet National and International laws and regulations and pertinent quality standards.
- Ability to create and process CAPAs in a team environment.
- Ability to create programs, processes, and work instructions in a team environment.
- Establish and maintain knowledge of US Governmental and International laws and regulations affecting the organization’s products and operations.
- Proactively scans existing literature and FDA submissions to identify risk.
- Responsible for training program for yearly repeat trainings and Quality-related training.
- Monitor and maintain the Device Investigation response.
Other
- Minimum of 5 years’ experience in FDA regulated industry and Regulatory Affairs
- Must have, or be eligible to obtain, a valid driver’s license and driving record within the standards outlined within Hanger’s Motor Vehicle Safety Policy and Procedures.
- Proven track record in Quality, Compliance, Regulatory Affairs
- Strong customer service and public relations skills
- Strong verbal and written communication skills
