Snellingis currently recruiting for an exceptionalRegulatory Affairs Specialist/Quality Management System Manager to administer/support/facilitate core processes of the Quality Management System (QMS) by international standards, regulatory requirements, customer requirements, and standard operating procedures herein referred to as QMS requirements.

Starting Salary: $70,000-95,000, DOE

Regulatory Affairs Specialist/Quality Management System ManagerEssential Duties and Responsibilities:

• Serve as the Process Owner for processes assigned by the Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned not limited to the maintenance of QMS, corrective action, preventive action, and process performance monitoring activities required to maintain compliance with QMS requirements.
• Manages document control for QMS-related documents and procedure development processes by QMS requirements.
• Manages corrective and preventive action processes by QMS requirements including follow-ups through completion and effectiveness checks
• Manages equipment management processes to include preventive maintenance and calibration activities by QMS requirements.
• Manages the reporting of QMS performance objectives and supporting activities.
• Manages QMS auditing processes and supporting activities.
• Monitors and reports on key performance indicators about quality processes to identify the need for corrective and preventive action.
• Ensures that processes needed for the quality management system (QMS) are implemented and maintained by requirements.
• Develop and implement strategies to support/maintain compliance with QMS requirements.

Regulatory Affairs Specialist/Quality Management System ManagerQualifications Needed:**

• Interdisciplinary team-building experience involving scientists, engineers, quality assurance, manufacturing, marketing, and other participants in the medical device industry.
• Working knowledge of FDAs QSR/cGMP, international standards, and Quality Assurance systems.
• Medical Device industry experience.
• Strong computer skills having advanced knowledge and experience with current word processing, spreadsheet, graphical, and file management software.
• Extremely detail-oriented with strong organizational skills and high-quality standards

Regulatory Affairs Specialist/Quality Management System ManagerEducation and Experience:

• Bachelor of Science Degree from a four-year accredited college or university; or five or more years of related experience and/or training.

Interested and qualified candidates for theRegulatory Affairs Specialist/Quality Management System Manager position should submit their resume to whittney@snellingbham.com for immediate consideration. Resumes will be reviewed as quickly as possible and qualified applicants will be contacted to set up an interview. For additional information, please contactWhittney Taylor at 205.879.9950

SNELLING is a full-service recruiting firm, placing candidates in temporary, temp-to-hire, and direct-hire positions in the Jefferson and Shelby County areas for over 70 years. SNELLING is a drug-free workplace. All inquiries are strictly confidential, and all search fees are paid by our clients. Contact us TODAY with confidence!