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.
Sr QA Compliance Auditor - 30602
Description
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.
Purpose/Role Statement
In this position, you will be responsible for conducting compliance audits at Boston Scientific facilities located in interesting and exciting locations in the U.S. and throughout the world. You will also plan and conduct requested audits of specific products, processes, or areas with the ability to apply and explain real world application of requirements, regulations and standards. You will be responsible for working with QA management/teams on validation, protocol and process reviews, and implementation of requirements in compliance programs
Key Responsibilities
• Plan and conduct scheduled Corporate quality system audits to assess compliance with FDA, ISO, MDD, and internal requirements, encompassing both Medical Device and Pharmaceutical Good Manufacturing Practices.
• Audit scheduling, investigation and presentation of audit observations, findings and reporting. Confirmation of follow-up actions is also key to this role.
• Participate in planning, coordination, and implementation of Corporate audit policies with Corporate and divisional leaders.
• You will receive extensive, up-to-date training in order to review, understand, and implement changes related to ISO, QSR and cGMP requirements.
• Incorporation of this information into Corporate and divisional programs through document reviews, protocol and validation reviews, and training programs, and participation with Corporate and divisional QA on policy/procedure/guideline development.
Qualifications
Candidate possesses a B.S. Degree with 5-7 years experience in quality and regulatory for medical devices and pharmaceuticals. Additional requirements for this position include the following: training in audit techniques and a comprehensive working knowledge of FDA regulations and ISO guidelines. Other, ideal requirements would include a minimum of five years experience in Compliance Auditing in medical device, pharmaceutical and/or a comparable related environment, as well as certified auditor or lead auditor training. Knowledge of human anatomy and physiology is helpful.
Working Conditions
General office environment, with significant domestic and international travel to other BSC facilities for auditing and or/meetings and conferences.
*May not include all essential functions of the job such as all of the job’s physical/mental requirements
