Quality Engineer II

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.


JOB DESCRIPTION:

2nd shift Quality Engineer II

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• 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.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Menlo Park, CA location in the Structural Heart division. Structural Heart Business Mission: why we exist 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

What You'll Work On

• 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
• 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
• 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
• Individual influence is typically exerted at the peer level.
• 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

Required Qualifications

• 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

Preferred Qualifications

• 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

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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The base pay for this position is
$81,500.00 - $141,300.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality


DIVISION:
SH Structural Heart


LOCATION:
United States > Menlo Park : 3885 Bohannon Drive


ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard


TRAVEL:
Not specified


MEDICAL SURVEILLANCE:
No


SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)


Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.


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