Senior Quality Engineer

Job Responsibilities:

• Lead the design, implementation, and maintenance of a comprehensive Quality Management System (QMS) aligned with FDA 21 CFR Part 820, ISO 13485, and EU MDR 2017/745.
• Develop scalable, phase-appropriate procedures adaptable to diverse client and product requirements across global regulatory markets.
• Author and manage quality documentation including master quality manuals, SOPs, and technical quality agreements for external partnerships.
• Ensure design controls and manufacturing processes adhere to applicable medical device and combination product standards.
• Conduct internal audits and system assessments to demonstrate readiness for FDA, ISO, and EU MDR inspections and certifications.
• Lead risk management activities in accordance with ISO 14971, ensuring integration of risk-based principles throughout design and manufacturing stages.
• Collaborate closely with cross-functional teams in validation, operations, and technical services to implement compliant, efficient quality practices.
• Support regulatory submissions by preparing and maintaining QMS documentation required for domestic and international filings.
• Provide technical guidance on change control processes and ensure system updates maintain compliance and traceability.
• Drive continuous improvement initiatives to enhance product quality, efficiency, and compliance maturity.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline (advanced degree preferred).
• 7+ years of experience in medical device or combination product quality systems.
• Demonstrated knowledge of FDA QSR (21 CFR Part 820), ISO 13485:2016, and EU MDR 2017/745 frameworks.
• Strong understanding of risk management (ISO 14971) and regulatory documentation requirements for both U.S. and EU markets.
• Experience working with or within contract manufacturing organizations (CMOs) supporting regulated medical products.
• Skilled in client and auditor interactions with proven success managing complex regulatory compliance landscapes.
• Proficiency in quality documentation systems, change control, and CAPA methodologies.