Senior Supplier Quality Engineer - Pleasanton, CA

Calyxo • Pleasanton, CA

10d • $155,000 - $163,000

About The Position

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.

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 relevant county, state, and Federal rules regarding vaccinations.

Responsibilities

• 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.

Benefits

• A competitive base salary range of $155,000 - $163,000 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior