Quality Specialist / Engineer

Looking for a Quality individual who has expeirence with SPC (statistical process control) and working in Excel or Power BI. This role would be working for a medical device company and a degree is not required.

The primary focuses are: Statistical Process Controls, Calibration and Project Management with customers. As an outcome of customer-related audits, this position will develop new strategies to exceed customer satisfaction. Implements and coordinates project progress, statistical data analysis and KPI creation. Position will have a high focus on existing product performance and new product development. SOPs, work instructions, inspection forms, DHRs, batch records and document approval will be essential parts of this role.

ESSENTIAL FUNCTIONS

• Work closely with Manufacturing, Engineering, Quality and Regulatory to analyze, investigate, implement and document processes for daily quality control, quality assurance
• Ensure Calibration frequency is met for all calibrated instruments. Execute and maintain a schedule and timing for all metrology related instruments and calibrations.
• Streamline and manage process steps to ensure they are clear and concise and work with all departments to achieve continuous improvement progress, meet deadlines and exceed customer satisfaction for periodic reviews, internal and supplier goods inspections, NC/CAPA trending and calibration program management.
• Interface with quality department peers to provide documentation, statistical process, validation methodology, and services to meet customer and regulatory requirements as directed.
• Perform functions as directed to support quality management and company management team.

QUALIFICATIONS

• At least 1+ years of expeirence with SPC and Excel or Power BI
• Experience working in quality and medical device, pharmaceutical or regulated ISO 13485 industry
• Willing to be fully onsite M-F
• Able to pass background check and drug screen
• Degree preferred but not required for this role

Medix is acting as an Employment Agency in relation to this vacancy.