Senior Manager, Design Quality

Role Overview

• Owning and continuously improving the Quality Management System, with a particular focus on the product development lifecycle.
• Overseeing the development of comprehensive test plans and validation strategies to ensure product compliance across the product portfolio.
• Driving design and process verification and validation efforts cross-functionally.
• Supporting quality event processes, such as CAPA, nonconformance, and complaint handling.
• Developing and maintaining robust risk management frameworks.
• Managing a team of quality engineers responsible for design controls and product risk management.
• Maintaining the quality manual, SOPs, and applicable standards.
• Leading audit readiness and supporting regulatory inspections.
• Collaborating with site leadership on training program development.

Requirements

• 10+ years of experience in quality engineering or quality leadership, with demonstrated lifecycle ownership of regulated products.
• Proven experience leading or hosting regulatory audits (CLIA, NYDOH, ISO 15189, ISO 13485, IEC 62304, ISO 27001, FDA CFR).
• Strong track record managing and developing teams in a regulated product environment.
• Bachelor’s or advanced degree in engineering, biomedical engineering, or a closely related field.

Benefits

• Medical, dental, and vision
• Flexible PTO and paid holidays
• Parental leave
• 401(k) with company match