Job Description

Additional Locations: US-DC-Washington; US-FL-Orlando; US-GA-Alpharetta; US-GA-Atlanta; US-GA-Macon; US-IL-Chicago; US-MA-Boston; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minneapolis; US-NC-Raleigh/Durham; US-NY-New York City

Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work.

Senior Clinical Quality Assurance Specialist

** This position can be field based anywhere in the U.S. preferred location Maple Grove, MN/Marlborough, MA

About the role:

Develops, establishes and maintains Clinical Quality Assurance programs, policies, processes, procedures and controls governing the Interventional Cardiology Clinical Function. Partners with Clinical trial teams to ensure the efficient and compliant implementation of the good clinical practices regulations/standards. Conducts clinical audits at investigator sites and clinical vendors.

Your responsibilities will include:

* Responsible for the development of clinical audit procedures and processes.
* Support the Clinical organization in meeting BSC Quality system requirements
* Plans, schedules, and conducts desktop vendor audits
* Plans, schedules and conducts desktop process/document audits
* Conducts investigator site audits
* Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners and Quality Manager providing quality input
* Supports clinical teams in gathering and reporting various performance metrics for quarterly BU Management Review meetings
* Participates in annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
* Support and leads the inspection readiness program focusing on proactive inspection readiness, tools and communication
* Supports the preparation, coordination, and management of regulatory agency sponsor inspections

What we are looking for in you:

Minimal qualifications:

* Bachelors degree in Life Sciences and 5-7+ years of experience
* Experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines;
* Demonstration of BSC Core Values and growth mindset
* Up to 10-15 % domestic and international travel required. Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.

Preferred qualifications:

* Clinical QA and/or compliance experience preferred
* GCP auditing certification desired

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen.

Requisition ID: 474197