Job Summary:

Direct ISO / FDA / Regulatory activities.

Interface with all personnel to develop, implement and support all company policies / procedures required to meet ISO/FDA/ Regulatory requirements. Maintains and monitors Quality Control and Documentation Control activities and duties and provides training.

Essential Functions:

• Develop, implement and monitor a Quality System in compliance with the FDA, ISO and regulatory requirements.
• Documents, complies, reports and assists in analyzing the data obtained through various testing and auditing functions performed to report in Management Review meetings.
• Development and performance of quality system audits.
• Interacts with all company personnel to support quality system functions and to promote awareness of regulatory requirements.
• Trains company personnel in quality related functions such as the use inspection equipment, sampling programs, inspection techniques, ISO and regulatory requirements, ect.
• Reviews and dispositions discrepant products identified through production and inspection.
• Maintaining and monitoring of customer complaints and returns.
• Maintain the CAPA and Calibration systems.
• Monitors and directs Quality Control and Documentation Control activities.
• Management Representative
• Other duties as assigned.

Qualifications:

• BS/BA or a combination of education and experience providing equivalent knowledge.
• Experience in the medical device industry as a Quality Manager required.
• Excellent communication skills, written / verbal with the ability to read and interpret various formats of technical documents required.
• Quality Auditing experience and formal training required.
• ISO/FDA / Regulatory requirements (implementation and maintenance of) required.
• Experience with computers, basic inspection equipment and calibrations required.
• Leadership skills required.

Job Type: Full-time

Benefits:

• 401(k)
• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Work Location: In person