Senior Quality Systems Engineer

Recruiter: Spencer Gregory Hale

Senior Quality Systems Engineer

About the role: This Senior Quality Systems Engineer role is responsible for owning and executing CAPA activities within the field action and quality systems processes to drive continuous improvement and close identified gaps. The individual will lead CAPAs end-to-end—from planning through execution and delivery—while collaborating cross-functionally with subject matter experts to identify root causes and implement effective solutions. This role requires a professional who can work within a matrix organization, coordinate across teams, and independently manage multiple quality system initiatives. The position is designed to strengthen CAPA ownership and enhance overall quality system performance, with a focus on regulated environments and continuous improvement efforts.  
 
Your responsibilities will include:

• Support site CAPA and NCEP activities as a SME, mentor and/or trainer


• Track and trend CAPA and NCEP related information and report at various review boards to a broad audience


• Champion quality and compliance to quality requirements throughout the NCEP and CAPA process


• Lead and/or support timely implementation of projects within the Arden Hills Quality Operations organization, including continuous improvement projects


• Work with Quality and other leaders to identify areas within NCEP/CAPA in need of improvement and lead such improvements


• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities


• Contribute actively to internal BSC global Communities of Practice

Required qualifications:

• Bachelor's degree


• Minimum of 5 years of related experience in quality engineering or quality systems engineering within a regulated industry


• Demonstrated CAPA and Nonconforming Product (NCP) experience


• Proven ability to own and drive CAPAs end-to-end (planning, execution, and delivery)


• Strong problem-solving skills with the ability to identify root cause and implement solutions


• Proficiency with Microsoft Office Suite

Preferred qualifications:

• Experience in medical device industry


• Experience supporting field action / PIR processes or similar quality system improvement initiatives


• Demonstrated ability to drive continuous improvement efforts within quality systems


• Exposure to or experience with global or multi-site environments

Requisition ID: 630173 

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 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 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 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.