Senior Quality Systems Engineer - Axonics (Onsite, Irvine, CA) at Boston Scientific Corporation Malaysia

Irvine, California, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Jan, 26

Salary

164500.0

Posted On

09 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Audits, Change Control, Document Control, Risk Analysis, Leadership, Regulatory Implementation, Software Validation, Coaching, Cross-Functional Collaboration, EU MDR, ISO 13485, MDSAP, 21 CFR 820, Microsoft Office Suite, Quality Systems

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: 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 Guide cross-functional teams on complex Quality System initiatives, including regulatory implementation, site expansion, system hybridization, and software validation Provide coaching and mentoring to other team members 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 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 Demonstrated ability to write and implement Quality System procedures Self-starter with a proactive mindset and high personal integrity Requisition ID: 614895 Minimum Salary: $ 86600 Maximum Salary: $ 164500 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. 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! 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. 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. 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. 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.

Responsibilities

Support Quality Management Reviews, internal and external audits, and provide leadership in designing and integrating large-scale Quality System changes. Guide cross-functional teams on complex Quality System initiatives and provide coaching and mentoring to other team members.