Director – Design Quality Assurance

Summary:

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.

In This Role, You Will:

• Lead the Design Quality Assurance team and ensure compliance with applicable domestic and international regulatory standards (e.g., FDA, CE marking, etc.).
• Oversee 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. 
• Partner with R&D to ensure product development activities and deliverables are compliant with internal procedures, external standards and regulations, and industry best practices.
• Provide Quality Engineering leadership, resources, and support to ensure the on-time development and commercialization of quality products.
• Oversee and direct Quality staff to ensure ample coverage and support for the R&D team to support new product development (NPD)and sustaining product engineering.
• Responsible for overseeing, planning, leading and driving activities such as Risk Management, Biocompatibility, Shelf-Life Studies, Test Method Validation, Reliability Engineering, and Statistical Analysis in support of new product development, product changes, and sustaining product engineering.
• Ensure robust design control, software development and risk management practices are followed, driving improvements in test methods, validation, and verification processes.
• Champion quality engineering principles and foster a company-wide continuous improvement mindset, promoting shared responsibility for quality.
• Responsible for talent management including recruiting, engaging, training, and developing quality staff to ensure the necessary skill sets and competencies to meet business needs.
• Establish, foster, and maintain successful cross-functional relations with internal departments/functions such as Operations/Manufacturing, R&D/Engineering, Regulatory and Clinical Affairs.
• Interface with all departments to provide leadership on the use of Quality Assurance and Engineering methodologies, tools and regulatory compliance requirements
• Serve as Subject Matter Expert for areas of responsibility during internal and external audits
• Work in accordance with the quality system procedures related to work activities.
• Develop, establish, monitor, and report on functional quality objectives, metrics, and goals.
• Manage department expenses in-line with approved department budgets.
• Supporting department specific initiatives and projects as assigned.
• Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Who You Will Report To:

• Vice President, Quality and Management Representative

Requirements:

• Education: 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.
• Work location: Pleasanton, CA.
• Travel: Ability to travel 10 - 15% Domestic and International to suppliers and contract manufacturing sites.
• Full-time employment.
• Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO 13485 and 14971, 62366; IEC 60601-1, IEC 62304 and related regulations.
• In depth knowledge of Risk Management, Biocompatibility, and Sterilization.  
• Strong written, oral, interpersonal skills, analytical skills, problem-solving techniques, and statistical application experience.
• Proactive leader who can determine deficiencies, communicate them effectively through the organization, and follow through to resolution.
• Excellent level of organizational skills and ability to direct and oversee multiple projects/initiatives at the same time with a high level of attention to detail.
• Strategic yet hands-on when needed; high degree of energy and drive; and the ability to continually seek to make improvements to the function, process and people being led.
• Excellent leadership and managerial skills with the ability to be flexible, adaptable and to work under pressure.
• Experience with FDA Class II sterile devices.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer an attractive compensation package, which includes:

• A competitive base salary of $200,000 - $230,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation