Apply on Employer Site

BD · 1 month ago

Quality Systems Engineer 2

USA PA - Zelienople

Full-time

Onsite

Mid Level

3+ years exp

BD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Quality Systems Engineer (QSE) is responsible for sustaining and improving the company’s Quality Management System (QMS) to ensure compliance with regulatory requirements and to drive continuous improvement initiatives.

Health CareMedical DeviceTechnical Support

Comp. & Benefits

No H1B

Responsibilities

Maintain and continuously improve core QMS processes including CAPA, Change Control, Document Control, Training, and Management Review

Serve as a subject matter expert (SME) for Quality System processes, providing guidance to multi-functional teams

Develop, implement, and maintain key performance indicators (KPIs) and quality metrics to drive visibility and continuous improvement

Prepare and present QMS performance data for Management Review and other quality forums

Lead the end-to-end CAPA process, including root cause analysis, effectiveness checks, and closure

Facilitate CAPA Review Board meetings, ensuring timely and effective decision-making and documentation

Partner with functional leaders to drive accountability and effectiveness in corrective and preventive actions

Oversee the Change Control process to ensure effective evaluation, risk assessment, and implementation of changes

Define and implement standard processes and training to strengthen change governance multi-functionalonal engagement

Find opportunities to streamline QMS processes, improve compliance efficiency, and enhance usability of quality systems

Support internal audits and regulatory inspections as a process owner or SME

Contribute to the development and rollout of digital tools or automation supporting QMS improvements

Qualification

Quality Management SystemCAPA ManagementChange ControlQuality Metrics21 CFR Part 820ISO 13485ISO 14971Electronic Quality Management SystemsCertified Quality EngineerCertified Quality AuditorAnalytical SkillsProblem-Solving SkillsCollaboration SkillsCommunication Skills