Position Summary:
The Quality Systems Coordinator will supports the calibration, maintenance, and training programs across multiple sites, ensuring compliance with policies and procedures. The role will also involve administrative support for quality system processes and database management.
Responsibilities:
- Calibration & Maintenance: Manage calibration and maintenance schedules for multiple sites, coordinate with external vendors, conduct audits, and support related audits and documentation.
- Training: Maintain training databases, ensure timely employee training, collaborate on training plans, and support audit activities.
- Quality Management: Collaborate with QA on process improvements, generate quality data, and review/author investigations (Complaints, NC, CAPA) and SOPs.
Qualifications:
- Education: Bachelor's Degree in Science or 5+ years of quality/documentation experience.
- Experience: 3+ years in a regulated cGMP environment; knowledge of FDA CFR QSR, ISO 13485.
- Skills: Strong computer, communication, analytical, and problem-solving skills. Compliance with company policies and safety regulations.
*Full job description to be provided
*No C2C
