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The Director, Design Quality Assurance provides strategic representation, planning, management, direction, and guidance to meet quality engineering goals and objectives supporting new product development and sustaining commercial products. This position directs and oversees Quality Engineering staff who contribute to and support new product development and sustaining of commercial products. The role provides leadership in defining and implementing quality engineering policies, principles and processes that facilitate the realization of Calyxo’s product development objectives. As an integral member of Calyxo’s Quality Leadership Team, this position fosters greater teamwork, alignment, collaboration, accountability, and performance between Quality and R&D. This position requires experience creating, developing, implementing, managing, overseeing and improving systems and processes, and the ability to drive performance and service at the highest level in a fast-paced, high growth, dynamic medical device environment. Responsibilities include leading the Design Quality Assurance team and ensuring compliance with applicable domestic and international regulatory standards (e.g., FDA, CE marking, etc.), overseeing Design Quality Assurance and Engineering activities including the development, documentation, implementation and maintenance of quality system requirements and procedures related to design, development, and pre-production manufacturing activities, partnering with R&D to ensure product development activities and deliverables are compliant with internal procedures, external standards and regulations, and industry best practices, providing Quality Engineering leadership, resources, and support to ensure the on-time development and commercialization of quality products, overseeing and directing Quality staff to ensure ample coverage and support for the R&D team to support new product development and sustaining product engineering, managing activities such as Risk Management, Biocompatibility, Shelf-Life Studies, Test Method Validation, Reliability Engineering, and Statistical Analysis, ensuring robust design control, software development and risk management practices, championing quality engineering principles and fostering a company-wide continuous improvement mindset, talent management including recruiting, engaging, training, and developing quality staff, establishing and maintaining cross-functional relations with internal departments, serving as Subject Matter Expert during audits, developing and reporting on functional quality objectives, managing department expenses, and supporting department initiatives and projects. The role requires a Bachelor of Science in Engineering or Life Science discipline, minimum 15 years experience in Quality Engineering/Assurance in the medical device industry including 5 years in a managerial role, strong knowledge of FDA requirements for design control of medical devices and related regulations, in depth knowledge of Risk Management, Biocompatibility, and Sterilization, strong communication and analytical skills, proactive leadership, excellent organizational and managerial skills, experience with FDA Class II sterile devices, and compliance with vaccination rules. The position is full-time based in Pleasanton, CA with 10-15% travel.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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