Full Description
Location: Menlo Park, CA
Contract: 9 months. (Potential to extend further)
JOB DESCRIPTION:
The responsibilities mentioned indicate that this role involves overseeing the quality of components sourced from suppliers, ensuring compliance with corporate and divisional policies and procedures, and driving improvements and corrective actions where necessary.
Will work on Mitra Clip device
Here is a breakdown of the key responsibilities mentioned in the job description:
Assess potential new suppliers: Evaluate potential new suppliers based on their technical, quality, and manufacturing capabilities. Provide technical support during the introduction of components from new suppliers.
Develop incoming inspection procedures: Establish procedures for incoming inspection and train inspectors accordingly.
Source inspection tools and equipment: Identify and procure the necessary tools and equipment required for effective inspection processes.
Assist in generating component specifications: Collaborate with relevant teams to develop detailed specifications for components.
Generate test protocols: Create test protocols, monitor testing processes, and issue
qualification test reports for components to be used in products.
Provide input to Design Engineering: Offer insights on new component technology and assist in component selection, emphasizing quality and reliability analysis.
Analyze incoming material defects: Analyze defects in incoming materials, determine appropriate actions, and communicate issues to suppliers for corrective measures.
Review design specifications: Review new design specifications from a component quality and manufacturability perspective, providing valuable input.
Investigate field failures: Investigate field failures related to supplier materials and develop corrective action plans where necessary.
Qualifications:
This role requires a Bachelor's degree in engineering or a related scientific field.
3 -5 years experience required.
Medical Device experience required.
Test Method development experience required
Supplier Validation experience required
Exp with smaller pieces
Additionally, the individual is expected to work within a quality system environment, potentially leading a project team and providing guidance to less experienced staff. Non-compliance with job responsibilities can lead to potential breaches of governmental regulations.