Supplier Quality Engineer

Role: Supplier Quality Engineer

Duration: 3-month+ contract

Hourly: $55.00 - $60.00

onsite in Los Gatos

POSITION DESCRIPTION:

The Supplier Quality Engineer will ensure products and services provided by suppliers meet quality standards. This position represents an exciting opportunity to join an innovative company and shape its supplier management process. As the key member of quality team, you will be taking a variety of quality responsibilities, including working with other members of the procurement and operations team, and other duties as assigned.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Collaborate with suppliers, contract manufacturers, and business partners to ensure robust materials, components, and processes.

• Lead supplier qualification, audits, requalification, and supplier quality agreement activities.

• Own and drive Supplier Quality projects, initiatives, and continuous improvement efforts.

• Partner with Procurement, R&D, Operations, and Supply Chain to resolve supplier-related issues and prevent disruptions.

• Monitor supplier performance metrics, identify risks, and drive improvement actions.

• Manage supplier corrective action processes (SCARs), including tracking, aging metrics, and effectiveness.

• Support and/or lead supplier-related CAPAs, nonconformances (NCRs), and investigations.

• Conduct failure analysis on supplier components and drive root cause and corrective actions.

• Implement and manage supplier change control processes, including impact assessment and approvals.

• Lead component and supplier qualification and change projects.

EDUCATION/EXPERIENCE

• Bachelor’s degree in engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and experience.

• Experience with catheters, endovascular/neurological devices is highly desired

• Experience in medical devices (catheters, endovascular, or neurological) preferred.

• Experience in both product and supplier quality engineering is strongly preferred.

• Experience addressing supplier or process issues (NCRs, SCARs, etc.)

• Demonstrated knowledge of quality system requirements (FDA QMSR, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices

• Excellent communication skills (both written and verbal)

• Proven ability to provide thorough and meticulous review of documents

• Proven ability to write clear, concise, and well thought out technical documentation with focus on failure investigations and inspection procedures

Benefits (Employee Contribution)

• Health Insurance
• Health Savings Account
• Dental Insurance
• Vision Insurance
• Flexible Spending Accounts
• Life Insurance
• Retirement Plan

If you are a motivated individual with a strong attention to detail and experience in document control, we encourage you to apply for this exciting opportunity to contribute to our dynamic team.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.