Senior Manager Quality Systems

Job Summary

A company is looking for a Senior Manager, Quality Systems.

Key Responsibilities:

• Develop and maintain quality system procedures according to FDA regulations
• Coordinate and lead QMS audits and corrective actions
• Prepare management reports on quality data and lead Management Review meetings

Required Qualifications:

• Bachelor’s degree in science, engineering, or related field
• 5+ years of Quality roles experience in the medical device industry
• Knowledge of FDA regulations, ISO standards, and experience with software applications in QMS
• Experience in implementing quality systems for efficiency
• Certification by ASQ and/or Lead Auditor Certified to ISO 13485 is a plus