Quality Engineer II

Abbott • Menlo Park, CA

9d • Onsite

About The Position

This position works out of our Menlo Park, CA location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. As the Quality Engineer II, you'll provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. You will also provide support to product development teams, helping to ensure development of highest quality new products. Second shift hours : Monday - Thursday 3 PM - 1 AM

Requirements

• Bachelors Degree in a related or an equivalent combination of education and work experience
• 2- 5 years related work experience with a basic understanding of specified functional area
• Basic technical knowledge of concepts, practices and procedures
• Ability to work 2nd shift hours

Nice To Haves

• Prior medical device experience preferred
• Experience working in a broader enterprise/cross-division business unit model preferred
• CAPA owner or a key cross-functional team member leading a CAPA project
• Use of quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Risk management, post market surveillance, and manufacturing analysis

Responsibilities

• Learns to identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions
• May be responsible for working with process owner to bound product stops and document release criteria
• Gains understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems
• May be responsible for learning risk analyses and FMEAs
• Learns Process Monitoring Systems by becoming familiar with systems applications and critical process steps. and through familiarization with methods used to reduce process variation
• Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development.
• Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
• Begins developing a network of internal resources to facilitate completion of tasks
• Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks
• May exercise authority within pre-established limits and approval. Failure to achieve results can normally be overcome without serious effect on schedules and programs

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level