Quality Systems Analyst

San Diego, CA
Apr 16, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Quality Systems Analyst will play a critical role in implementation of the Bionano Genomics Quality Management System (QMS). In this role the incumbent will be responsible for coordinating and facilitating Quality Assurance (QA) standards based on ISO 13485. The position will develop and maintain quality systems, monitor production conformance per standard operating procedures as well as participate in creating methods for improving product quality.

Essential Duties and Responsibilities:

  • Participates in the implementation, development, management and integration of the Bionano Genomics QMS
  • Serve as a Quality Systems resource for problem identification, CAPA and reporting
  • Review and release quality records (including manufacturing batch records, work instructions and other related documents) for each production lot
  • Participate in the design, release and implementation of documentation for process control, process improvement, inspection and test
  • Implement and maintain metrics (first pass yield, process capability and control charts) for management review and monitoring system effectiveness
  • Disposition non-conformances, perform root-cause analysis, and implement corrective action to drive process improvements
  • Maintain collection and analysis systems of statistical data to predict trends that will improve product quality
  • Assist in product and process validation activities
  • Report to management on quality issues, trends, and yields
  • Participate in internal and external quality audits
  • Interface with suppliers regarding supplier performance and assure that effective corrective action is implemented
  • Assist in Document Control activities and Change Control Board meetings
  • Other duties as assigned or identified

Job Requirements:

  • Bachelor's degree in Science, Engineering, or other relevant field
  • Five (5) years Quality Assurance experience in a cGMP medical device, biotech or pharmaceutical environment
  • Document control experience
  • Strong technical writing ability
  • Knowledge of ISO 13485, QSR (21 CFR Part 820), GLP, GCP, and GMP
  • Strong organizational skills, task oriented, excellent time management skills
  • Ability to multi-task; flexible and adaptable to changing priorities
  • Works well with limited supervision and as part of a team
  • Proven communication skills. Demonstrate ability to negotiate assigned tasks with other departments
  • Lifting up to 50 pounds may be required