Principal Quality Systems Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)
Software Engineering, Quality Assurance
Sacramento, CA, USA · arden hills, mn, usa
USD 102,100-194k / year
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:
This Principal Quality Systems Engineer serves as a Design Control representative leading awareness, visibility, and communication of quality initiatives in support of global and CRM quality goals. This role is responsible for compliance of the CRM Design Control to BSC Global Quality System and applicable regulatory requirements and standards.
Work Mode:
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.
Relocation Assistance:
Relocation assistance is not available for this position.
Visa Sponsorship:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.
Your responsibilities will include:
- Deliver and manage completion of CRM divisional deliverables, including updates to procedures, Work Instructions, and knowledge sharing documents
- Active membership of Global Procedural and Design Control Community of Practice
- Drive and provide guidance to team members regarding quality strategies driven by BSC Global Quality System
- Provide project direction, coaching, and mentoring for engineering and technical team personnel
- Work cross-functionally in identifying and resolving procedural issues
- Drive continuous improvement initiatives to enhance CRM Design Control Process and its efficiency while maintaining or improving product quality
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Advise management on potential improvements or enhancements to quality systems and processes in the company.
- Promote a culture of quality and compliance within the organization through regular communication and training.
- Provide essential support during internal and external audits by presenting Design Control storyboard in front room and addressing questions related to CRM DC process. Provide back room support by supplying necessary documentation and leading DC backroom stream.
- Establish or maintain CRM design control procedures, templates, and tools
Required Qualifications:
- Bachelor’s degree in science, Engineering, Health, or related fields
- Minimum of 8 years of work experience in the medical device or other regulated industry
- Solid computer skills required including Excel, Word, and PowerPoint
- Strong communication skills (verbal and written)
Preferred Qualifications:
- Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485:2016
- Project management experience
- Experience within BSC quality systems
- Experience with Design Control process
- Experience working with cross functions teams such as Regulatory, Research and Development, Clinical, and Quality
- Strong presentation skills
- Travel is very limited, maybe up to 10%
Requisition ID: 636093
Minimum Salary: $ 102100
Maximum Salary: $ 194000
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 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.
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. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.
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 Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test 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.