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, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
About This Role:
Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls. Interface with key internal stakeholders including Corporate, Site, and Business Unit representatives. May serve as liaison between the company and various governmental agencies. Work directly with operating entities to ensure that Post Market Surveillance product complaint management processes are performed as required. May manage work done offsite and through 3rd party vendors. Work closely with CCC and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.
Your Responsibilities Will Include:
- Defining best approaches and statistical techniques to product performance during launch, sustainment, and EOL
- Define and lead strategy advancement of technical insight and product performance improvement
- Recruit, coach, develop, and lead organizational talent.
- Provide oversight to work done offsite and by 3rd party vendors.
- Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
- Develop and maintain Post Market Compliance programs, policies, and processes.
- Develop and facilitate training and training support for the Post Market Surveillance organization.
- Work cross-functionally to identify and resolve issues.
- Determine appropriate staff levels, schedules and resources.
- Act as an effective leader in supporting quality disciplines, decisions, and practices.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Drive projects of major magnitude and scope.
What We're Looking For In You:
- Bachelor's degree plus 7-9 years of related work experience and people leadership or an equivalent combination of education and work experience
- Leadership in problem-solving across engineering and cross-functional teams
- Experience achieving product improvement across DA, operations, supply chain, supplier, and field-based organizations
- Strategy in technical failure analysis and/or data analytics
- Results in effective people leadership, project management, strategy, and influential communication
- Experience leading across systems of capital equipment and SUD for IC
- Experience with multisite partnerships with Galway and Coyol
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 you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Requisition ID: 468651