Quality Analyst - Easton, United States - CryoConcepts

Description

• Manage QMS documentation and quality records;
• Review quality records and perform batch record review for final release of product;
• Identify essential documentation concerns, discrepancies or compliance issues;
• Process documents within electronic quality management systems and act as eQMS administrator;
• Assist with and ensure completion of Nonconformance and Planned Deviations;
• Participates is the Corrective and Preventative (CAPA) process, including investigations, root cause analysis and action plan assignment. Tracks and monitors CAPA investigation, CAPA plans, implementation, and surveillance;
• Coordinates the execution of the Calibrated Equipment Program;
• Perform product complaint entries, product complaint investigations, product complaint close out reports and participate in product complaint review calls with customer(s)
• Assist in analyzing company data, including customer complaints and nonconformance reports (NCRs), for patterns or trends; identify potential problems before they occur;
• Maintains the data collection and reporting of specified quality metrics and key process indicators; assist with data review and preparation for management review;
• Prepare with supplier qualification activities;
• Manage training documentation.

• Bachelor?s degree in Life Sciences or related discipline;
• 3+ years? experience in a regulated industry (medical devices preferred);
• String experience with quality management systems;
• Thorough knowledge and understanding of FDA 21 CFR Part 820, ISO 13485:2016 and MDSAP;
• Experience with an electronic management or quality management system;
• Experience supporting regulatory inspections is preferred;
• Strong Microsoft office skills;
• Strong organization and time management skills;
• Strong problemsolving skills;
• Ability to handle several deliverables simultaneously;
• Demonstrated ability to be flexible and deal with frequent changes;
• Must work well independently and as a collaborative team;