Lead Quality Systems Engineer

2 weeks ago

Quincy, Illinois, United States Boston Scientific Full time
Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we empower you to leverage your full potential by collaborating with a diverse and high-achieving workforce, addressing some of the most significant challenges in the healthcare sector. With access to cutting-edge tools, resources, and training, we are committed to helping you enhance your skills and advance your career. Here, you will find support in pursuing your aspirations.

About the position:
The Senior Quality Systems Engineer is responsible for developing, establishing, and sustaining quality-engineering methodologies, systems, and practices that comply with BSC, customer, and regulatory standards. Act as a Quality representative to elevate awareness, visibility, and communication regarding quality initiatives to support departmental, functional, site, divisional, and corporate quality objectives. Provide quality engineering assistance within technical development concepts, regulatory frameworks, operational, or system/services support.

Your key responsibilities will include:
  • Utilizing technical quality engineering principles to assigned processes or projects and guiding their implementation.
  • Identifying and executing effective process control systems to ensure the ongoing distribution of products that meet or surpass internal and external quality and regulatory standards.
  • Employing systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Analyzing Quality data for management reporting (CAPA Review Board, Quality Management Review) and advising management on potential enhancements to quality systems and processes within the organization.
  • Planning and conducting scheduled quality system audits to evaluate compliance with FDA regulations, ISO standards, MDD, and internal requirements, including audit scheduling, investigation, evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions.
  • Ensuring readiness for external audits.
  • Coaching and mentoring teams on applying Corrections and Corrective actions, supporting team members by setting an example and providing feedback/guidance on Root Cause Analysis (e.g., Investigation, Risk Assessment, Solution, VOE).
  • Assessing site compliance with new or revised Global processes.
Required qualifications:
  • Bachelor's degree or higher in engineering, life sciences, technology, or a related field.
  • 5+ years of experience in the healthcare industry, focusing on process investigation and drafting scientifically justified conclusions linked to true root cause (CAPA Process).
  • Experience as a Lead Auditor for at least one (1) internal audit.
  • Willingness to travel up to 25%.
Preferred qualifications:
  • Completion of an external Lead Auditor Training/Certification Program (e.g., ASQ or ComplyGuru ISO 13485:2016 Certified Lead Auditor Training).
  • Ability to exchange complex information with others, potentially guiding and persuading them.
  • Regular participation in discussions and presentations in small, cross-functional meetings, logically presenting information to convey key messages.
  • Experience with Supply Chain and/or Distribution processes.
  • Advocacy for a Preventive Quality and Value Improvement Process culture.
Requisition ID: 588022

Boston Scientific is committed to maintaining a diverse and inclusive workplace, which we believe fosters innovation and is essential in our mission to advance science for life and enhance patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding environment for our employees and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

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