Supplier Quality Engineer

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Job Title: Supplier Quality Engineer
Job Description
We are seeking a highly skilled Supplier Quality Engineer to support a specialized medical device project. This is a temporary role focused on documentation and supplier quality activities for pre-designed components. The ideal candidate will bring deep experience in medical device manufacturing, supplier qualification, and regulatory compliance. Responsibilities
Qualify suppliers and ensure their components meet design control requirements. Perform supplier audits and manage supplier quality assurance processes. Update documents related to the manufacturing process, including the Approved Supplier List (ASL). Onboard new vendors and assess vendor risk documents. Manage corrective and preventive actions (CAPA) and non-conformance reports (NCR). Challenge and ensure the quality of work provided by suppliers. Essential Skills
Experience in supplier quality and supplier audits. Knowledge of ISO standards and medical device regulations. Ability to manage documentation and supplier quality assurance. Experience with molded components and thermoformed parts. Additional Skills & Qualifications
Engineering degree preferred, but a four-year degree demonstrating critical thinking is acceptable. Experience with contract manufacturers is acceptable. Work Environment
The role operates within a stable medical industry environment, recently acquired by private equity, with a focus on the development of new products. The culture promotes a healthy mindset of teamwork and problem-solving without finger-pointing. Work hours are from 9am to 5pm with occasional preplanned overtime. Pay and Benefits
The pay range for this position is $50.00 - $50.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type
This is a fully onsite position in Santa Clara,CA. Application Deadline
This position is anticipated to close on Aug 6, 2025.
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Location:
Santa Clara

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