Principal Quality Systems Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)
Core
Design Control representative leading awareness, visibility, and communication of quality initiatives in support of global and CRM quality goals, ensuring compliance of the CRM Design Control to BSC Global Quality System and applicable regulatory requirements.
Role type
Principal Quality Systems Engineer (Medical Device)
Builds
CRM divisional deliverables including updates to procedures, Work Instructions, and knowledge sharing documents
Domain
Medical Device / Cardiac Rhythm Management & Diagnostics
Required skills
Design Control expertise, Quality System compliance, Regulatory standards knowledge, Systematic problem-solving, Cross-functional collaboration, Process improvement, Mentoring, Audit support, Procedure development, Strategic guidance
Responsibilities
Deliver and manage completion of CRM divisional deliverables including updates to procedures and Work Instructions; Drive and provide guidance to team members regarding quality strategies; Provide project direction, coaching, and mentoring for engineering and technical team personnel; Work cross-functionally in identifying and resolving procedural issues; Drive continuous improvement initiatives to enhance CRM Design Control Process; Apply sound, systematic problem-solving methodologies in identifying and resolving quality issues; Advise management on potential improvements to quality systems; Promote a culture of quality and compliance through regular communication and training; Provide essential support during internal and external audits by presenting Design Control storyboard and addressing questions; Establish or maintain CRM design control procedures, templates, and tools