Senior Supplier Quality Engineer 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.

Summary:

TheSeniorSupplier Quality Engineer (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 ofCalyxosmanufacturing and product development objectives.

In This Role You Will:

• Serve as the primary quality and technical interface betweenCalyxoand 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/recordsincluding 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 drivecorrective 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.

• Fostereffective 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 toCalyxosSupplier Quality Management program.

• Supporting department specific initiatives and projects as assigned.

Who You Will Report To:

• Director Operations & Supplier Quality Assurance

Requirements:

• Education: Bachelor of Science in Engineering or Life Science discipline.

• Minimum8yearsexperiencein Quality Assurance; minimum5yearsexperiencein Supplier Management / Supplier Quality Engineer.

• Work location:Pleasanton CA

• Travel:Ability to travel20 - 30% Domestic and Internationaltosupplier/CM sites

• Full-time employment

• Knowledge of applicable national and international quality system requirements and standards such as FDA QSR ISO 13485 ISO 9001and 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.

WhatWeOffer:

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 attractivecompensation package which includes:

• A competitivebasesalary range of $155000 - $163000and variable incentive plan

• Stock options ownership and a stake in growing amission-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 onlyvalued but alsoprioritized. 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 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. If you receive a request for information from any other domain please contact us directly at 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.