Pre Clinical QA Auditor – Osseo

Delivering on the promise of medical innovation begins at Boston Scientific

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.

Fulfill quality assurance requirements specified by FDA and international GLP regulations. Ensure the quality and integrity of preclinical data is submitted to regulatory agencies. Prepare Preclinical Sciences for successful regulatory inspections.

Responsibilities:

• Review or audit study-related activities and documentation (e.g., protocol audits, crucial phase inspections, data and report audits, etc.) for compliance with protocol, SOPs, and GLP regulations. Issue audit statement when appropriate.
  
• Perform vendor audits (e.g., test facilities, test sites, consultants) and internal audits of the Preclinical Sciences department, test facilities, and test sites for compliance with GLP regulations.
  
• Write and distribute audit reports that describe audit findings.
  
• Enter audit information into an audit database.
  
• Track audit findings and corrective actions. Document completion of corrective actions.
  
• Develop departmental SOPs, work instructions, templates, and forms.
  
• Consult with, and advise, Preclinical Sciences; research associates and managers and BSC core teams on GLP compliance issues.
  
• Participate in or lead departmental projects/initiatives
  
• Build quality into all aspects of work by maintaining compliance to all quality requirements.
  
  Qualifications:
  
• Bachelor’s/Master’s degree; major in biology, chemistry, or other scientific field preferred.
  
• 2-3 years of relevant experience (e.g., medical device, preclinical research) with Bachelor’s degree, 0-2 years with Master’s.
  
• Knowledge of FDA and international GLP regulations and guidelines.
  
• Strong communication (oral and written and interpersonal skills).
  
• Available to travel 10-25 percent of time.
  
  Apply Here