Senior Supplier Quality Engineer - Pleasanton, CA

Calyxo, Inc. is a medical device company seeking a Senior Supplier Quality Engineer to select, manage, and maintain the supply base, execute supplier process validations, and drive acceptable supplier performance.

Requirements

• 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
• Ability to travel 20 - 30% Domestic and International to supplier/CM sites
• 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

Benefits

• 401(k)
• Healthcare insurance
• Paid vacation