- The Sr. Compliance Engineer will support the external inspection and audit management of the site.
- Implement proactive compliance initiatives. Provide compliance guidance to the site, including compliance support for Quality improvements and remediation activities.
- Serve on cross-site and cross-segment project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements. Support in the management of internal and external audit observations to ensure identified gaps or systemic risks are identified and closed in a robust and timely manner.
- $110K-$150K. Relocation provided.
- The Sr. Compliance Engineer will have a BS or MS degree with an engineering major.
- 8 + years of experience in an FDA regulated industry.
- Knowledge of ISO 13485 and 21 CFR 820 is required. Experience leading internal Quality System audits is required. International regulations.
- The ability to travel to 15% (mostly regionally) is required.
- Must be legally eligible to work in the U.S. and have a stable work history. Sponsorship is not available.