Senior Quality Systems Engineer - Axonics (Onsite, Irvine, CA)

 

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:

As a Senior Quality Systems Engineer within the Axonics business unit at Boston Scientific, you will play a critical role in shaping, improving, and maintaining our Quality System to ensure ongoing compliance with global regulatory standards - including EU MDR, FDA, Health Canada, Australia TGA, and others. Based onsite in Irvine, CA, you will contribute to both strategic projects and day-to-day operations, providing expert guidance on Quality System requirements and helping to implement transformative changes across the organization. This is a high-impact opportunity to support best-in-class audit readiness, drive continuous improvement, and work cross-functionally with teams advancing innovation in the neuromodulation space.

 

Work model, sponsorship, relocation:

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

 

Your responsibilities will include:
• Implement, defend, monitor, improve, and integrate the Axonics Quality System to meet Boston Scientific and global regulatory requirements
• Support Quality Management Reviews (QMRs), internal and external audits, audit responses, change control, document control, and risk analysis
• Provide leadership in designing and integrating large-scale Quality System changes and improvements
• Serve in front room, back room, and SME roles during audits
• Guide cross-functional teams on complex Quality System initiatives, including regulatory implementation, site expansion, system hybridization, and software validation
• Lead the design and rollout of hybridized and fully integrated Quality System processes, including SOPs, forms, job aids, training, and post-go-live support
• Own and manage NCEP and CAPA records as applicable
• Proactively identify and implement process improvements, preventive CAPAs, and Value Improvement Projects (VIPs)
• Provide coaching and mentoring to other team members
• Regularly lead discussions and deliver presentations to cross-functional audiences

 

Qualifications:

 

Required qualifications:
• Bachelor’s degree in science or engineering and a minimum of 5 years' experience in medical device/Quality Systems – or – Master’s degree and a minimum of 3 years' experience in medical device/Quality Systems
• Demonstrated ability to lead and manage projects through execution
• Strong working knowledge of EU MDR, ISO 13485, MDSAP, 21 CFR 820, and related regulations and standards
• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, Visio, and SharePoint

 

Preferred qualifications:
• Bachelor’s degree in engineering or equivalent experience
• Experience in at least two of the following areas: Quality Systems, Document Control, Design Quality, Manufacturing Quality / Production & Process Controls, or Supplier Quality
• Familiarity with global regulatory programs such as EU MDR, 21 CFR 820, MDSAP, and ISO 13485
• Strong cross-functional collaboration experience, including working with global teams
• Excellent interpersonal, communication, and presentation skills
• Demonstrated ability to write and implement Quality System procedures
• Self-starter with a proactive mindset and high personal integrity

 

#LI-Hybrid

 

 

 

Requisition ID: 614895 

Minimum Salary: $ 86600 

Maximum Salary: $ 164500 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors con