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:

The Senior Supplier 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 of Calyxo's manufacturing and product development objectives.

In This Role, You Will:

* 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:

* Director, Operations & Supplier Quality Assurance

Requirements:

* Education:

Bachelor of Science in Engineering or Life Science discipline.

* Minimum 8 years experience in Quality Assurance; minimum 5 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…