Principal Quality Compliance Analyst

Additional Location(s):  N/A; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.       

About the role: The Principal Quality Compliance Analyst identifies, develops, establishes, maintains, and improves quality systems methodologies, systems, and practices which meet BSC, NMD, customer, and regulatory requirements. Serves as key Quality representative to improve awareness, visibility, and communication on quality system initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality systems compliance support within new product development, operational, or system/services support. Demonstrates great aptitude in interpreting and applying external quality system management regulations and standards.  Works closely with Med Safety to support Health Hazard Assessments, works with Product Performance Engineers and Risk SMEs to support risk management files/updates/changes as it pertains to PIRs/CAPA support.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Supports Quality System PIR and Field Action sub-process through managing and supporting the PIR/FA process
• Maintains collaborative relationship with Regulatory Agencies, specifically FDA.
• Authors, executes, and supports all aspects of Field Action documentation working closely with Post Market Communication team, regulatory and Field Actions teams.
• Identifies, develops, establishes, maintains, and improves quality systems methodologies, systems, and practices which meet company and regulatory requirements.
• Serves as an expert-level Quality representative to improve awareness, visibility, and communication on quality system initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
• Provides focused quality systems compliance expertise within product development, operational, or system/services support.
• Advanced-level aptitude in interpreting and applying external quality system management regulations and standards. 
• Provides project direction, coaching, and mentoring for quality system personnel at all levels of the organization.
• Bridge the gap on the Global vs local Quality System documentation by proactive review and assessment.
• Drives improvement within the organization as well as global level improvement and changes to support QMS, CAPA, PIR etc
• Supports the development team on strategy and compliance around, new product development, sustaining and HFA (Human Feasibility Assessment studies.