About the Job

The System Quality Analyst on the Enterprise Quality and Compliance Engineering team works with a diverse team of software engineers, product owners, architects, quality engineers and cross functional departments regulatory, quality assurance, computational biology, Engineering and IT to ensure compliance with the Quality Management Systems along with GxP documentation. The System Quality Analyst is responsible for tracking Technology CAPAs, NCRs and CAPA action items. The System Quality Analyst supports Internal and External Audits and working with teams to track and resolve findings/observations. The position requires technical and communication skills, and the ability to thrive in a fast-paced growing company. 

Key Responsibilities

• Tracking Technology CAPAs, NCRs, Deviations and CAPA Action Items; which includes the review of trended data to identify areas for improvement. 
• Initiation, Maintaining and communicating annual training plans (21CFRPart 11, Periodic Access assessment initiation.) 
• Supporting External and Vendor Audits and working with Product Owners for resolving observations and findings. 
• Supporting Internal Audits and working with Product Owners for resolving observations and findings. 
• Supporting health authority inspections. 
• Maintaining audit documentation. 
• Continuously improving the process and working with SDLC Operations team to influence changes to SOPs, Policies, Work Instructions and Forms. 
• Maintenance and archiving of documentation associated with the Quality Management System. 
• Assists in the scheduling and maintenance of Quality Assurance activities and systems. 
• Tracking of training documentation. 
• Maintain requirement and design specifications as well as other documentation required for software development and change control processes. 
• Work independently as well as collaborate in a larger team setting. 
• Demonstrate attention-to-detail, problem-solving, and ability to make decisions quickly. 
• Author and revise documentation of environment and operation procedures as needed. 
• Maintain availability to work outside of regularly scheduled shift. 
• Other duties as assigned. 

Qualifications

Basic Qualifications

• Bachelor's Degree 
• 4+ years of experience in a related area, with a focus on testing or requirements management 

Preferred Qualifications

• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products 
• Familiarity with requirements definition and management as related to a software development life cycle 
• Experience with Good Practice (GxP) quality guidelines and specific regulations, including but not limited to: 
  • Clinical Laboratory Improvement Amendments (CLIA); 
  • Good Clinical Practice (GCP); 
  • College of American Pathologists regulations; 
  • 21 CFR Part 11 compliance; 
  • Food and Drug Administration and FDA Good Manufacturing Process; 
  • Massachusetts state regulations; and, 
  • New York state regulations 
• Familiarity with IEC 62304, CAPA , NCR Process 
• Strong interpersonal skills that include skills in written and oral communication, collaboration, and problem solving with departments and colleagues 
• Excellent attention to detail 
• Understanding of HIPAA and importance of privacy of patient data 
• Commitment to FMI’s core values: patients, passion, collaboration, and innovation