Senior Software Quality Engineer Global Device Software Steward Support
Job Location:
Maple Grove, MN - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Recruiter: Spencer Gregory Hale
SeniorSoftware Quality EngineerGlobalDeviceSoftwareSteward Support
Travel amount:Up to 10%
Remote Eligible:Hybrid
Onsite Location(s):Hybrid inMN
About the role:
This Device Software Sub-Process Steward Support role teams with the Device Software Sub-Process Steward to help with leadership and oversight to the Device Software sub-process. The Device Software sub-process controls device software considered a finished medical device or used as a component part or accessory of a medical device developed subcontracted modified or purchased. Quality System Stewards use the Best4 (Culture Agility Performance Compliance) Strategy to enable our Quality Quality System Device Software sub-process maintain oversight of all processes in their assigned Sub-Process. Sub-Process Stewards work together to maintain their assigned Process(es) and ensure all responsibilities are fulfilled.
Your responsibilities will include:
Best Culture:
SustainDevice SoftwareCommunityofPractice (CoP).
Provide subject matterexpertisefor the organization and collaborate with site/divisional experts.
Write applicable annual quality goals andobjectiveswith input from sites divisionsregionsand leadership to align with Best4 and organizational strategies. Support and update goals andobjectivesthroughout the year.
Best Agility:
Monitor Device Software Sub-Process and implement process improvements based on performance feedback.
Drive value improvement projects (VIP) to support organizational goals.
Support acquisition integration as needed.
Increase Quality System simplicity efficiency and predictability with standardization and lean practices.
Maintain andenhancesinternal and external relationships in support of the Global Quality SystemProcess/Sub-Process.
Best Performance
Monitor and mitigate Quality System Process compliance risk whereappropriate.
Lead or oversee quality projects of majormagnitudeand input to overall qualityproject portfolio and project priorities.
Determineif changes are reportable to notified bodies.
Initiative corporate preventive CAPAs and own orparticipatein corporate preventive CAPA teams.
Create implement and sustain measures and metrics tomonitorDevice SoftwareSub-Process health.
Provide metricsdataand analysis for management review.
Best Compliance:
Establish andmaintainGlobalQuality System Device Software Sub-Processto ensure compliance with applicable quality and regulatory requirements.
Review of new Laws RegulationsStandards andGuidances (LRGS)andthe implementation of new requirements into the BSC Quality System.
Communicate new and updated requirements.
Provide subject matterexpertiseand support for corporate and site internal and external audits.-
Review quarterly dataperQuality System ProcessCompliance Assessment.
Support theauditnon-conformance response strategies.
IdentifyGlobalQuality System DeviceSoftwareSub-Processtraining requirements.
Support corporate NCEP & CAPA Processes.
Assess reportability of substantial Quality System Changes.
Ensuring quality records are createdmaintainedand dispositioned.
Required Qualifications:
Bachelors level degree in Science/Engineering/Computer Science/Software Engineering disciplineand/orMinimum of4years of related experiencein the Medical Device regulated industry.
Working knowledge of regional and international quality system requirements including 21 CFR 820 ISO 13485IEC 62304; ISO14971; FDAGuidance General Principles of Software ValidationandComputer Software Assurance for Production and Quality System Software.
Must havegoodunderstanding of quality system requirements and how each quality system element connects.
Comfortable speaking and presenting to leadership
Strong written and verbal communication skillsin English
Experience managing projects and project deliverables to completion
Comfortable working independently and as part of a cross-functional team
Ability to manage multiple priorities
Proficient in Microsoft Office
Works willingly and effectively with others in and across the organization toaccomplishteam goalswith excellent interpersonal and networking skills.
Values peoples opinions and encourages knowledge levelof energydriveand enthusiasm
Knowledge ofSoftware Engineering Principles andSoftware Development Life Cycle (SDLC)
Ability to work independently and collaborate with cross-functional teams to complete projects
Strong critical thinking and analytical skills: process and results-oriented
Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively
Preferred Qualifications:
Device Software Engineering Experience including:
Device SoftwareDevelopment
Device Software Testing / Verification
Risk Management
Cybersecurity
Artificial Intelligence / Machine Learning
Agile Practices
Experiencein supporting and enhancing theQMSprocessesincluding:
Device Software Development
Design Controls
Risk Management
Post Market and PremarketCybersecurity
Experience working with Medical DeviceSoftwareAdvocacy Standards and Professional Organizations(; MDIC; IEC; FDA;AdvaMed; NIST; IMDRF)
Formal Project ManagementExperience
CAPA Vendor Controls ComplaintHandlingandInternal/External AuditsExperience
Software Development Tools Experience(; Cockpit;Github;Codenvy;Bitbucket)
Requisition ID:630662
Minimum Salary:$85000
Maximum Salary: $161500
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.
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.
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.
Required Experience:
Senior IC
About Company
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