Calyxo, Inc. · 3 weeks ago
Manager, Supplier Quality Engineer - Pleasanton, CA
Pleasanton, CA
Full-time
Onsite
Senior Level, Lead/Staff
$155K/yr - $195K/yr
12+ years expCalyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA, focused on improving kidney stone treatment. The Supplier Quality Engineer Manager will be responsible for developing and overseeing the Supplier Quality Engineering program, managing supplier performance, and ensuring compliance with quality standards while collaborating with internal departments.
Health CareMedicalMedical DeviceWellness
Responsibilities
Implement and maintain the effectiveness of the Quality System as it relates to Supplier Quality Management
Develop, prioritize, provide direction and monitor progress toward Supplier Quality Engineering department goals, objectives, and initiatives
Manage Supplier Quality Engineering staff to ensure ample coverage and support for Operations and R&D projects and product approval and release activities as it relates to external suppliers
Ensure the Calyxo Approved Supplier List and corresponding supplier files are maintained and accurate
Drive and support continuous improvement plans and activities at suppliers
Ensure appropriate validation and qualification of applicable supplier processes, methods and equipment at suppliers
Ensure the on-time completion of all required supplier maintenance activities such as quality audits/assessments, process audits, business reviews/assessments, regulatory assessments, quality contract/agreements and performance monitoring/feedback with suppliers
Serve as Subject Matter Expert (SME) during internal and external audits as it relates to Calyxo’s Supplier Quality Management program
Ensure the hiring and development of qualified Supplier Quality Engineering staff, provide growth path/opportunities and professional development and guidance as appropriate
Establish and maintain successful cross-functional relations with internal departments/functions such as Operations/Manufacturing, R&D/Engineering, Quality Control and Regulatory Affairs
Manage department expenses in line with approved department budgets
Fulfill day-to-day Supplier Quality Engineer activities as described in the Supplier Quality Engineer job description, as necessary
Support department specific initiatives and projects as assigned
Domestic and International travel to suppliers and contract manufacturers as needed (15-30%)
Qualification
Required
Bachelor of Science in Engineering or Life Science discipline
12+ years overall experience in Quality Engineering/Assurance with a minimum of 5 years in Supplier Quality Engineering; minimum 5 years experience in medical device manufacturing or pharmaceutical industries
Minimum of 5 years of experience managing and developing teams, with proven ability to lead people, set priorities, and drive departmental goals in a regulated quality environment
Demonstrated knowledge of applicable regulations and standards such as FDA, QSMR, ISO, MDR, & IVDD
Strong written, oral, and interpersonal skills
Trained and experienced Lead Auditors in conducting external Quality System assessments (preferably a Certified Lead Auditor)
Strong analytical skills, problem solving techniques and statistical application experience
Knowledge in the areas of Supplier Management, Design Controls, Process Validation, manufacturing practices, and statistical techniques
Preferred
Experience with Class II and III sterile devices
Benefits
Stock options – ownership and a stake in growing a mission-driven company
Employee benefits package that includes 401(k), healthcare insurance and paid vacation
Company
Calyxo, Inc.
Calyxo, Inc.
201-500 employees
H1B Sponsorship
Calyxo, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
$125.44MKey Investors
Avidity Partners
2024-12-26Series Unknown· $28.28M
2023-12-12Series D· $50M
2022-07-06Series C· $32.7M
Leadership Team
Joseph Catanese
President & CEO
Doug Hughes
Chief Financial Officer
Recent News
2025-12-18
2025-10-21
Medical Product Outsourcing
2025-09-13
Company data provided by crunchbase