Principal Quality Systems Engineer

Boston Scientific•Alpharetta, GA

56d•$99,100 - $188,300•Onsite

About The Position

We are seeking a strategic and experienced Principal Quality Systems Engineer to join our Quality team at the Johns Creek site. In this key role, you will serve as the subject matter expert (SME) on the Corrective and Preventive Action (CAPA) system, leading initiatives that enhance our quality systems and ensure compliance with global regulatory requirements. You'll partner cross-functionally to promote a culture of continuous improvement, audit readiness, and quality accountability-driving Boston Scientific's mission of transforming lives through innovative medical solutions.

Requirements

Minimum of 5 years' experience in quality systems, quality engineering, or related function in the medical device, pharmaceutical, or regulated industry.
Bachelor's degree in engineering, life sciences, or related technical field.
In-depth knowledge of CAPA processes, root cause analysis, and structured problem-solving methods.
Strong understanding of QSR, ISO 13485, cGMP, and EU MDR standards.
Experience supporting or leading regulatory inspections (e.g., FDA, Notified Bodies).
Excellent verbal and written communication skills, with the ability to influence across levels and functions.

Nice To Haves

Prior experience with eQMS tools (e.g., TrackWise, Agile, MasterControl).
Previous experience mentoring or leading others in quality system practices.
Experience with quality metrics and data analysis to drive improvement.

Responsibilities

Act as the SME for the CAPA system, managing and mentoring on CAPA and nonconformance processes.
Lead preparation for and participation in external audits (e.g., FDA, ISO, MDSAP), including coaching staff on audit readiness best practices.
Serve as a quality representative to increase awareness, visibility, and communication on quality initiatives across departments.
Provide quality systems support to ensure compliance with Boston Scientific's Quality System requirements and assess system effectiveness.
Benchmark and implement best practices tailored to business needs while aligning with regulatory requirements and operational goals.
Serve as a recognized leader in QSR, cGMP, ISO, and EU MDR standards; collaborate with the QA Director on critical quality decisions.
Lead and support internal audits; identify opportunities for advancing the Quality Systems at the Johns Creek site.
Monitor and report on quality metrics that drive continuous improvement and customer satisfaction.
Champion cross-functional collaboration to align teams on quality and compliance goals.
Cultivate a culture of accountability, customer focus, and ownership of quality responsibilities.
Provide coaching and guidance to engineering and technical teams to strengthen quality capabilities.
Apply structured problem-solving methodologies to address quality issues and communicate resolutions effectively.
Track action items, report site metrics, and lead Management Review and CAPA Review Board meetings.
Monitor progress against quality plans and escalate risks to leadership when necessary.
Advise leadership on strategic quality system improvements that support long-term business objectives.