Quality Systems Senior Engineer II

Quick Facts

• Role: Quality Systems Senior Engineer II

• Focus: Quality Management System (QMS) for advanced robotic surgical systems

• Travel: Up to 25%

• Compensation: $100,000 - $124,000 USD / annual

Description

Responsible for leading the implementation, maintenance, and continuous improvement of a Quality Management System (QMS) supporting the design, development, verification, validation, and commercialization of advanced robotic surgical systems. Provides technical leadership for document control, change control, training, audit readiness, electronic QMS, and quality system compliance. Partners with cross-functional teams to ensure compliance with FDA QMSR, ISO 13485, and company procedures.

Responsibilities

• Lead or support the implementation, maintenance, and continuous improvement of the QMS.
• Develop, implement, and maintain Document Control and Change Control processes aligned with FDA QMSR, ISO 13485, and company procedures.
• Lead or support the Monogram Training Program, ensuring assignments, completion, effectiveness, and training record compliance.
• Serve as the Quality Systems subject matter expert for Greenlight Guru and future enterprise electronic QMS platforms (e.g., Windchill, ETQ, CodeBeamer).
• Develop, maintain, and continuously improve Quality System procedures, work instructions, forms, templates, and records.
• Partner with Engineering, Regulatory Affairs, Clinical Affairs, Operations, and Supply Chain to ensure Quality System compliance throughout the product lifecycle.
• Support regulatory submissions by ensuring controlled, complete, accurate, and inspection-ready Quality System documentation.
• Lead or support internal audits, certification/customer audits, and regulatory inspections; coordinate audit responses and timely corrective action implementation.
• Lead or support PQS assessments, HHED/HHE determinations, Issue Evaluations, NCRs/deviations, CAPAs, and root cause investigations; interface with product risk management processes.
• Develop Quality System metrics and KPIs to monitor effectiveness and drive continuous improvement.
• Lead or support quality system harmonization initiatives with corporate Quality Systems.
• Provide technical leadership and mentoring to Quality Systems personnel and cross-functional teams.
• Stay informed of FDA regulations, ISO standards, and industry best practices; implement improvements as appropriate.
• May lead cross-functional projects and assume supervisory responsibilities as business needs evolve.

Benefits

• Development opportunities
• Robust employee resource groups (ERGs)
• Flexible working environment
• Location-specific competitive total rewards
• Wellness incentives and recognition/performance awards

Requirements

• Bachelor’s degree in Engineering and 5 years of relevant experience (or equivalent experience)
• 6+ years of progressive Quality Systems experience within the medical device industry (highly preferred)
• Experience with FDA-regulated medical devices and ISO 13485
• Experience leading Document Control, Change Control, Training, and Audit programs
• ASQ Certified Quality Auditor (CQA) or Certified Manager of Quality/Organizational Excellence (CMQ/OE) (or equivalent) preferred
• Ability to travel up to 25%