Director, Operations & Supplier Quality Assurance

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

The Director, Operations & Supplier Quality Assurance provides strategic representation, management, direction, guidance, and alignment for all aspects of Quality Assurance/Engineering supporting Calyxo's manufacturing and operations activities. These aspects include Manufacturing Quality Engineering, Supplier Quality Engineering and Quality Control.

As an integral member of Calyxo's Quality Leadership Team, this position fosters greater teamwork, alignment, collaboration, accountability, and performance across all quality functions in supporting manufacturing and operations to meet current and future business needs and objectives.

This position requires experience creating, developing, implementing, managing, 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:

• Motivate and lead a high performing Manufacturing Quality and Supplier Quality Engineering team.
• Responsible for talent management including recruiting, engaging, training, and developing quality staff to ensure the necessary skill sets and competencies to meet business needs.
• Oversee Quality staff to ensure ample coverage and support for Manufacturing and Operations.
• Direct quality assurance and engineering activities including the planning, development, documentation, implementation and maintenance of quality requirements, policies, procedures and practices related to areas of responsibility
• Oversee, develop, and ensure an effective Supplier Quality Management program (in collaboration with Operations) to support existing products and new product development (in collaboration with R&D) to achieve desired performance metrics and manufacturing/operations and R&D objectives and goals.
• Oversee, develop, and ensure an effective Quality Control function providing for incoming inspection, in-process inspection, finished device release, and on-request inspection as required to achieve desired product quality, performance metrics, and manufacturing/operations goals and objectives.
• Oversee supplier qualifications and process validations
• Ensuring that metrology equipment and test/inspection method development for and/or used by Quality Control are appropriately qualified/validated.
• Establish, foster, and maintain successful cross-functional relations with internal departments/functions such as Operations/Manufacturing, R&D/Engineering, Quality, and Regulatory Affairs.
• Identify and implement continuous improvement plans and activities to support Manufacturing and Operations in meeting current and future business needs.
• Interface with all departments to provide leadership on the use of Quality Assurance/Engineering methodologies, tools and regulatory compliance requirements.
• Provide strategic guidance, expertise, and input in the areas of responsibility supporting manufacturing and operations.
• 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:

• See Organization Chart

Requirements:

• Education: Bachelor of Science in Engineering or Life Science discipline.
• Minimum 15 years experience in Quality Engineering, Quality Assurance, and Supplier Quality in the medical device industry and a minimum of 5 years in a Quality Management role.
• Work location: Pleasanton, CA.
• Travel: Ability to travel 20 - 30% Domestic and International to supplier and contract manufacturing sites.
• Full-time employment.
• Exceptional Knowledge of applicable national and international quality system regulations, requirements and standards, such as 21 CFR Part 820 (QSR) ISO 13485, ISO 14971, ISO 10993, IEC 60601 and IMDRF Guidance on Process Validation.
• Trained and experienced Lead Auditors in conducting Quality System assessments (preferably a Certified Lead Auditor).
• Experience with electronics and printed circuit board assembly related processes
• Strong analytical skills, problem solving technique, and statistical application experience.
• Strong written, oral, interpersonal skills, analytical skills, problem-solving techniques, and statistical application experience.
• Excellent level of organizational skills and ability to direct and oversee multiple on 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.
• Experience with Class II or III sterile devices (preferred).
• 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 - $235,000 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

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Disclaimer:

At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of firstname.lastname@calyxoinc.com. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.