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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 exp

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA, focused on improving kidney stone treatment. The Supplier Quality Engineer Manager is responsible for developing and overseeing the Supplier Quality Engineering program, managing supplier performance, and ensuring compliance with quality systems and policies.

Health CareMedicalMedical DeviceWellness

No H1B

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

Supplier Quality EngineeringQuality System ManagementMedical Device ManufacturingRegulatory Standards KnowledgeLead Auditor CertificationAnalytical SkillsTeam ManagementStatistical TechniquesInterpersonal SkillsProblem Solving

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