Under the direction of the local Regulatory Compliance Manager, the auditor’s prime responsibility is to monitor and report the facility’s state of compliance versus FDA and ISO requirements. This is primarily accomplished through routine and special request internal audits. The auditor documents and reports to management on compliance issues. A secondary responsibility is to perform audits of proposed and existing suppliers to assess their quality systems. A third responsibility is to provide consultation services to the auditee in the form of options and suggestions in addressing the nonconformities.
Duties & Other Responsibilities:
- Conduct internal and external audits versus FDA and ISO requirements.
- Document audit results and coordinate the resolution of subsequent CAPA actions.
- Maintain current knowledge of FDA, ISO, (including risk management), and industry requirements.
- Train personnel on requirements of FDA and ISO.
- Investigate potential compliance issues and keep management informed of findings.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Perform special projects and other duties as assigned.
Professional Experience & Educational Requirements :
- Minimum of 4 years quality/compliance experience in medical device and/or pharmaceutical industries. Experience with a broad range of related functions is preferred.
- Minimum of 2 years experience directly auditing in the medical device/pharmaceutical fields. Experience in auditing a broad range of related functions is preferred.
- Direct contact experience with FDA investigators and/or ISO registrars is preferred.
- Bachelor degree in science, engineering, quality or other technical field. Degrees in other fields may be considered depending on type and experience within the medical device / pharmaceutical field.
- Documented training in FDA Quality System Regulation (QSReg), ISO 13485, and ISO 9001.
Brittle, broken, battered bones cease to be a problem with Synthes around. The company makes devices, instruments, and implants used for the...