Quality Compliance Fellow

Additional Location(s): 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 Design Quality Assurance Fellow will develop, establish and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional quality goals and priorities.  Serves as a liaison for development teams to support compliance related project goals.  Collaborates with Quality management to recommend, design and implement functional process improvements and guidance on compliance related matters.  May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate. 
 
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.  
• May author, executes, and will 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.  
• Supports the organization by combing the business needs with compliance and setting the right strategy for success.  
• Assesses local and global processes and establishes the most efficient path to drive the organization forward.  
• Works as a liaison between Med Safety and PIR team, by working with the CIS team to drive data as needed to support complex CAPAs or PIR activities  
• Works with CAPA team to support and drive risk evaluations and updates  
• Is responsible for CAPA sign off for all CAPA resulting from PIRs  
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Required qualifications: 

• Bachelor’s of science degree 
• Minimum of 10 years relevant experience, preferably in medical device industry  
• Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management:  21 CFR Part 820, ISO 13485, AIMDD, MDD, MHLW, MDR SOR/98-282, 21 CFR Part 211, ISO 14971  

 
Preferred qualifications: 

• Master’s degree and 7+ years relevant experience, preferably in medical device industry or other regulated industry  
• Experience working on PIRs or evaluations supporting field action decisions  
• Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements  
• Excellent verbal / written communication, interpersonal, project management, and organizational skills; must be able to multi-task, and analyze information quickly  
• Ability to communicate with all levels of the organization  
• Must be able to work independently, lead and / or participate as part of a team  
• Must be proactive, work independently, and be a contributing member of a highly visible team  
• Must have working knowledge of Medical device product deve