Quality Systems Coordinator

JOB DESCRIPTION POSITION / JOB SUMMARY: This position will be based in the Santa Fe Springs, CA location, reporting to the Director of Quality Assurance. The Quality Systems Coordinator role will be responsible maintaining the calibration, maintenance, and training program across multiple sites. Administrative responsibility for key quality system processes. They will ensure that compliance is maintained and that employees are trained and following the required site level policies and procedures. Position Responsibilities / Essential Functions: Percentage Time 40% Calibration and Maintenance Maintains calibration and maintenance database for multiple sites, ensure all instrumentation is calibrated per a schedule Coordinates with external vendors for calibration and maintenance activities Conduct monthly calibration and preventative audits on equipment and records Provide QA review of data sheets, results, reports, etc. Completes documentation in electronic quality management system Supports audit activities related to calibration and maintenance practices Assess changes to critical equipment and serves as quality review for impact assessment. Initiate and process non-conformances for OOT equipment 40% Training Maintains training database for multiple sites, ensure training is performed in a timely manner. Collaborate with department managers to ensure training plans are prepared for all new hires and updated as appropriate for existing employees. Ensures employees are trained to all required procedures and follow up to confirm continued training to latest revisions Supports audit activities related to training practices 20% Supplier Management Assist in developing trend and evaluation reports for suppliers Maintains supplier files in a database Required Qualifications: Education: B.S. Experience: 2 years+ experience working in a regulated cGMP environment or 4+ years within quality or documentation in lieu of the degree Skills: Knowledge of quality principles applicable to medical device products, including FDA CFR QSR and ISO 13485. uniPoint experience preferred or another electronic QMS Experience in the Medical Device Industry or other similar fields. Strong computer skills including Microsoft Office Package Strong written communication skills and attention to detail are required Ability to understand manufacturing specification, requirements, procedures and departmental processes. Complies with all company policies and procedures, including safety rules and regulations Fosters a commitment to quality and a culture of quality across PRO-TECH Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle, or feel objects, tools, controls and office equipment. The Employee frequently is required to talk and hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus. Work Environment The work environment characteristics described herein are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually very quiet. Job Type: Full-time Pay: From $65,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Schedule: Monday to Friday Education: Bachelor's (Required) Experience: cGMP Environment: 3 years (Required) Work Location: In person