Sr Quality Systems Engineer - CAPA

Recruiter: Spencer Gregory Hale
Sr. Quality Systems Engineer - CAPA
About the role:
The Sr Quality System Engineer will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Specifically, this role will support the Corrective and Preventive Action (CAPA) program at Maple Grove and ensure compliance to CAPA processes, Medical Device regulations and BSC Quality System requirements.
This is a hybrid work mode position located in Maple Grove, MN with the expectation to be in the office 3 days per week.
Your responsibilities include:

• Mentoring cross-functional CAPA teams on:
  • applying quality tools and techniques to identify root causes and create sustainable solutions to product and/or system issues
  • using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical CAPA phase timelines
  • creating robust, compliant and timely records, using the electronic CAPA database system
• Providing continuous and rigorous assessment of CAPA activities and review of documentation throughout the CAPA lifecycle to ensure compliance with global BSC CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements
• Providing guidance to the CAPA team on activities, such as root cause analysis, corrective action plans and effectiveness verifications, and advising the team on applying sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic quality issues
• Being a subject matter expert in matters relating to CAPA at the Maple Grove site with the ability to make sound decisions and provide guidance regarding how to best apply the processes efficiently, effectively, and compliantly
• Determining and tracking actionable CAPA metrics and trends to ensure proper execution and effectiveness of the site CAPA program, including influencing key stake holders as appropriate
• Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects

Required Qualifications:

• Bachelor's degree and 5+ years or Master's degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment
• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• Technical writing and documentation skills
• Attention to detail and ability to analyze information quickly
• Use a risk-based approach for making quality and business decisions

Preferred Qualifications:

• Degree(s) in Science or Engineering
• 5+ years of experience in Quality Systems and/or CAPA management
• Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
• Proficiency in Power BI and Tableau data reporting tools
• Proactive, able to work independently, as a team leader or member, and enjoy being part of a highly visible team
• Ability to collaborate and communicate with all levels of the organization
• Continuous improvement mindset with a passion for Quality
• Hands-on Project Management experience

Requisition ID:
Minimum Salary: $ 82600
Maximum Salary: $
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 identify, 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.