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 well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll 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 - includingEU 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 is onsite and requires employees to work from our local office on a full-time basis. 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:
Bachelors degree in science or engineering and a minimum of 5 years experience in medical device/Quality Systems or Masters degree and aminimum 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:
Bachelors 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 vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications among other relevant business or organizational needs. At BSC it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly) non-sales roles may also include variable compensation from time to time (e.g. any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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) isnt just business its personal. And if youre 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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy the Company will continue to take steps to assure that recruitment hiring assignment promotion compensation and all other personnel decisions are made and administered without regard to race religion color national origin citizenship sex sexual orientation gender identity gender expression veteran status age mental or physical disability genetic information or any other protected class.

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 Companys policies or protocols change with regard to COVID-19 vaccination.

Among other requirements Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and as such candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.