Job Level
Mid-LevelSenior
About the role
- 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.
- Deal with FDA registration and 510K submission.
- Maintain GMDN, GS1, and GUDID submissions.
- Work with NPD team to create risk assessments and build quality into new product offerings.
- Lead the internal audit process with vendors and within internal functional areas as required.
- Ability to train new auditors.
- Maintains and further enhances a positive, engaged, accountable organizational climate.
- Actively engages with other internal functional areas and/or other affiliated Business Units to address and resolve issues for the organization.
- Projects a positive and professional image at all times.
- Assists in maintenance of Master Control QMS software processes.
- Inspects as needed.
- Performs audit, such as FDA, ISO, etc. unsupervised.
- Can run reports and gather data for AGW.
- Can assess the need for, and issue CAPAs when needed.
- Understands and can participate in improvements to the quality management systems.
- Can train/supervise and lead other employees.
Requirements
- Bachelor's degree in related field or equivalent work experience to substitute for the bachelor’s degree.
- Minimum of 5 years’ experience in FDA regulated industry and Regulatory Affairs
- Lead auditor training required
- 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.
- Preferred Lean / Six Sigma training preferred
- Master Control knowledge a plus
- Digital QMS knowledge a plus