Sr. Quality System Engineer

Additional Location(s):  N/A

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 Sr Quality System Engineer will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Specifically, this role will support the Corrective and Preventive Action (CAPA) program at Maple Grove and ensure compliance to CAPA processes, Medical Device regulations and BSC Quality System requirements.

This is a hybrid work mode position located in Maple Grove, MN with the expectation to be in the office 2 days per week. 

Your responsibilities include:

• Mentoring cross-functional CAPA teams on:
  • applying quality tools and techniques to identify root causes and create sustainable solutions to product and/or system issues
  • using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical CAPA phase timelines
  • creating robust, compliant and timely records, using the electronic CAPA database system
• Providing continuous and rigorous assessment of CAPA activities and review of documentation throughout the CAPA lifecycle to ensure compliance with global BSC CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements
• Providing guidance to the CAPA team on activities, such as root cause analysis, corrective action plans and effectiveness verifications, and advising the team on applying sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic quality issues
• Being a subject matter expert in matters relating to CAPA at the Maple Grove site with the ability to make sound decisions and provide guidance regarding how to best apply the processes efficiently, effectively, and compliantly
• Determining and tracking actionable CAPA metrics and trends to ensure proper execution and effectiveness of the site CAPA program, including influencing key stake holders as appropriate
• Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects

Required qualifications:

• Bachelor's degree and 5+ years or Master's degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment
• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• Technical writing and documentation skills
• Attention to detail and ability to analyze information quickly 
• Use a risk-based approach for making quality and business decisions

Preferred qualifications:

• Proactive, able to work independently, as a team leader or member, and enjoy being part of a highly visible team
• Ability to collaborate and communicate with all levels of the organization
• Continuous improvement mindset with a passion for Quality
• Degree(s) in Science or Engineering
• 5+ years of experience in Quality Systems and/or CAPA management
• Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
• Hands-on Project Management experience
   

Requisition ID: 557978

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.