Senior Quality Systems Engineer

Additional Location(s): US-MN-Arden Hills

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 Senior Quality Systems engineer will be part of the Global Quality Systems Team supporting the Headquarters site. Focus areas include supporting the improvement initiatives related to the Quality Management Review process and Signals Review meeting forum. This role will also support analysis of internal and external data to identify trends, signals and metrics that may be useful to drive improved decision making in both of these forums. Additional activities that support continued compliance to Quality System requirements and best in class audit performance will be identified and assigned as necessary.

This role acts as the representative to improve awareness, visibility, and communication on global initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Partner with functional teams across all divisions to drive and improve processes. 

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 is not available for this position at this time.

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

Your responsibilities will include:

• Supporting the organization’s improvement activities related to the Quality Management Review process and the quarterly Signals Review meetings.
• Review and trend internal and external data to identify signals, trends and other useful information that supports decision making.
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Advise on potential improvements or enhancement to quality systems and processes in the company.
• Lead or support projects within the Quality System Management team.
• Own NCEP and CAPA records as applicable to the role.

• Ensure the development and execution of streamlined business process which help achieve VIP/Continuous Improvement goals.
• Support internal and external audits on an as needed basis.

Required Qualifications:

• Bachelor’s degree in science and/or engineering and 6+ years medical device/Quality System experience or Master’s degree and 4+ years of medical device/Quality System experience.
• Proficiency with Excel, pivot tables and data analysis.

• Demonstrated competency working cross functionally and globally.

• Strong communication and presentation skills.
• Ability to develop effective, positive interpersonal relationships.
• Proficiency with Microsoft Office suite, including SharePoint.

Preferred Qualifications:

• Bachelors degree in engineering or equivalent experience
• Experience using Power BI
• Experience with regulations, including EU MDR, 21 CFR 820, MDSAP program and ISO 13485.
• Experience with NCEPs and CAPAs (non-conforming events and the corrective action process).
• Driven, energetic, self-assured professional with high personal integrity
• Experience updating, writing and implementing quality system procedures
• Familiarity with BSC systems such as Windchill, eCAPA

Requisition ID: 627057 

Minimum Salary: $ 89200 

Maximum Salary: $ 169500 

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.