Senior Quality Systems Engineer - Bolt Integration

About the Role

Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills

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.

This role follows a hybrid work model requiring employees to be in one of our local offices in MN, primarily Arbor Lakes or Arden Hills, MN at least three days per week.

Relocation assistance may be 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.

• Integration Support
  • Support integration of legacy processes and products into the BSC quality system.
  • Own and drive deliverables associated to integration execution in alignment with the global quality systems roadmap and overall program priorities.
  • Participate in and lead Communities of Practice activities to promote standardization and adoption of best practices.
  • Lead or support continuous improvement initiatives using structured methodologies to drive efficiency, scalability and operational excellence.
  • Identify, analyze and resolve quality system issues using systematic problem-solving methodologies.
• Audit and Compliance
  • Support standardization efforts and maintain audit readiness in accordance with applicable regulations and standards, including ISO 13485, 21 CFR Part 820 and EU MDR.
  • Support external audits and regulatory inspections through preparation, execution, back-room support and follow-up activities.
  • Develop training materials, audit support documentation and related compliance resources.
  • Serve as an audit-facing subject matter expert for assigned quality processes and digital quality systems.
  • Ensure compliance to external standards and regulations through the integration process, including maintenance of supporting documentation.
• Nonconformance & CAPA
  • Serve as an owner or lead contributor for nonconformance, exception and CAPA activities.
  • Serve as CAPA mentor.
  • Contribute to risk management activities and systemic issue resolution efforts.

Required qualifications

• Bachelor's degree in Engineering, quality, life sciences or a related field
• 5 years’ experience in quality systems within a regulated industry
• Working knowledge of regulations and standards applicable to the Boston Scientific Global Quality System and Document and Records Control processes, including ISO 13485, 21 CFR Part 820 and EU MDR.
• Demonstrated experience partnering with cross-functional stakeholders to support quality system processes
• Ability to travel up to 25%

Preferred qualifications

• Proven experience supporting audits and inspections
• Prior experience with CAPA activities
• Integration experience
• Proven ability to influence without authority

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare.

Boston Scientific Corporation is an equal opportunity employer. All hiring and employment decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veteran status, age, disability or genetic information.

Certain U.S. positions, including field sales and service roles that involve hospitals 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 for which they have applied requires proof of vaccination as a condition of employment. This role is also deemed safety-sensitive and subject to a prohibited substance test as a requirement.

Full benefits are available to employees in accordance with company policies and include health, dental, vision, and other standard corporate benefits. Employees are also eligible for variable compensation components such as annual bonuses and long-term incentives as applicable.