Senior Supplier Quality Engineer - Pleasanton, CA

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