Principal, Supplier Quality Engineering - Pleasanton, CA

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.

In This Role, You Will:

The Principal Supplier Quality Engineering (in collaboration with Operations & R&D) is responsible for selecting, managing and maintaining the supply base, executing supplier process validations/part manufacturing qualifications, driving acceptable supplier performance, leading supplier improvement activities/initiatives, and monitoring supplier performance in support of Calyxo’s manufacturing and product development objectives.

• Serve as the primary quality and technical interface between Calyxo and the supply chain (subcontractors, suppliers, and service providers).
• Perform supplier evaluations, supplier selection, and supplier maintenance activities to ensure selection of qualified and appropriate supplier to meet business needs.
• Conduct supplier audits/assessments and issue reports detailing audit findings and observations and drive closure of opportunities for improvement and non-conformance with the supplier.
• Drive and oversee process validation, mold validation, and part manufacturing qualification activities at suppliers to ensure acceptable process output and product quality.
• Execute and monitor progress toward supplier goals, objectives, and initiatives.
• Ensure the on-time completion of all required supplier maintenance activities.
• Maintain and control supplier files/records, including supplier selection/approval records, supplier certifications (if applicable), supplier correspondence and change notification, supplier corrective action requests (SCARs), and supplier maintenance records.
• Monitor, track and report on supplier performance and work with suppliers on quality issues (including SCARS, NCRs, Audit Findings) and drive supplier performance levels to support business needs/objectives.
• Review and analyze production/manufacturing data to determine the primary factors affecting product quality, yield, cost, and drive continuous improvement initiative with supplier as necessary.
• Lead and drive corrective and preventive actions related to supplier audit findings, nonconforming product/material and/or overall supplier performance to ensure effective resolution, desired product quality, and timely closure.
• Assist in the development, approval, and maintenance of material specifications, supplier requirements/instructions, quality assurance procedures, supplier agreements, and supplier documentation (e.g. Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.).
• Work with Quality Control, Operations and R&D personnel to identify opportunities for continuous improvement with respect to supplier quality, part inspection/testing, design for manufacturability, and capacity/throughput.
• Manage and lead supplier development and continuous improvement activities targeted at achieving department goals and meeting business needs/objectives.
• Foster effective cross-functional relationships with suppliers and internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control and Regulatory Affairs.
• Serve as Subject Matter Expert during internal and external audits as it relates to Calyxo’s Supplier Quality Management program.
• Supporting department specific initiatives and projects as assigned.

Who You Will Report To:

• See Organization Chart

Requirements:

• Education: Bachelor of Science in Engineering or Life Science discipline.
• Minimum 12years experience in Quality Assurance; minimum 7 years experience in Supplier Management / Supplier Quality Engineer.
• Work location: Pleasanton, CA
• Travel: Ability to travel 20 - 30% Domestic and International to supplier/CM sites
• Full-time employment
• Knowledge of applicable national and international quality system requirements and standards such as FDA, QSR, ISO 13485, ISO 9001 and GHTF Guidance on Process Validation.
• Trained and experienced Lead Auditors in conducting Quality System assessments (preferably a Certified Lead Auditor).
• Experience with manufacturing processes such as electrical, mechanical, packaging, sterilization, injection molding, extrusion, etc.
• Excellent level of organizational skills and ability to work and drive multiple projects at the same time with high level of attention to detail.
• Strong analytical skills, problem solving technique, and statistical application experience.
• Strong written, oral, and interpersonal skills.
• 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 a compensation plan as follows:

• Competitive base salary $170,000 - $185,000
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

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.