Quality Systems Sr Engineer II

What You Can Expect

Responsible for leading the implementation, maintenance, and continuous improvement of the 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 Quality Management Systems, and Quality System compliance. Partners with cross-functional teams to ensure compliance with FDA QMSR, ISO 13485, and company procedures.

How You'll Create Impact

• Lead or support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Develop, implement, and maintain Document Control and Change Control processes aligned with FDA QMSR, ISO 13485, and company procedures.
• Lead or support the development, implementation, and continuous improvement of the Monogram Training Program, ensuring training assignments, completion, effectiveness, and training record compliance.
• Serve as the Quality Systems subject matter expert for Greenlight Guru and future enterprise electronic QMS platforms, such as Windchill, ETQ, CodeBeamer, etc.
• 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 Quality System documentation is complete, accurate, controlled, and inspection ready.
• Lead or support internal audits, external/certification audits, and regulatory inspections, ensuring organizational readiness and successful outcomes.
• Coordinate audit responses and support timely implementation of corrective actions.
• Lead or support Product Quality Signal (PQS) assessments, Health Hazard Evaluation Determinations (HHEDs), Health Hazard Evaluations (HHEs), Issue Evaluations (IEs), Nonconformance Reports (NCRs), deviations, CAPAs, root cause investigations, and other Quality System activities, including appropriate interface with product risk management processes.
• Develop Quality System metrics and key performance indicators (KPIs) to monitor effectiveness and drive continuous improvement.
• Lead or support Quality System harmonization initiatives with Zimmer Biomet 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 and implement improvements as appropriate.
• May lead cross-functional projects and assume supervisory responsibilities as business needs evolve.

What Makes You Stand Out

• Comprehensive knowledge of FDA QMSR, ISO 13485, document control, records management, training systems, PQS, HHED/HHE, IE, NCR/deviation, CAPA, audits, risk management, and change control.
• Expertise with electronic Quality Management Systems (e.g., Greenlight Guru, SmartSolve, Windchill, ETQ).
• Experience leading or supporting internal, certification, customer, and regulatory audits.
• Excellent technical writing, communication, project management, and problem-solving skills.
• Ability to lead cross-functional initiatives and influence without direct authority.
• Strong analytical skills and continuous improvement mindset.

Your Background

• Minimum 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), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification preferred

Travel Expectations

Up to 25%

Expected Compensation Range

$100,000 - $124,000 USD / Annual