Boston Scientific
Senior Quality Systems Engineer - Axonics (Onsite, Irvine, CA)
Boston Scientific, Irvine, California, United States, 92713
Senior Quality Systems Engineer - Axonics (Onsite, Irvine, CA)
At Boston Scientific, we give you the chance to harness your potential by working with diverse, high‑performing teams and tackling critical health industry challenges. With the latest tools, information, and training, we support your skill and career advancement, allowing you to progress toward whatever ambitions you have.
About The Role As a Senior Quality Systems Engineer within the Axonics business unit at Boston Scientific, you will shape, improve, and maintain 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 strategic projects and day‑to‑day operations, providing expert guidance on Quality System requirements and helping 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.
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
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
Requisition ID: 614895
Minimum Salary: $86,600
Maximum Salary: $164,500
Boston Scientific is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, gender expression, veteran status, or disability status.
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About The Role As a Senior Quality Systems Engineer within the Axonics business unit at Boston Scientific, you will shape, improve, and maintain 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 strategic projects and day‑to‑day operations, providing expert guidance on Quality System requirements and helping 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.
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
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
Requisition ID: 614895
Minimum Salary: $86,600
Maximum Salary: $164,500
Boston Scientific is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, gender expression, veteran status, or disability status.
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