Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Santa Clara, CA location in the Structural Heart Division. Structural Heart Business Mission: Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

WHAT YOU’LL DO

• Responsible for performing in-process and final inspections for materials/components, sub-assemblies, final product, packaging, and labeling.

• Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions.

• Responsible for receiving inspection activities including but not limited to inspection and gathering all defined requirements and documentation to release parts/components.

• Understand the capability of measuring tools. Utilize small hand-tools, calibrated instruments, measuring equipment, microscopes and test fixtures.

• Understand engineering drawings and inspection requirements of components and parts.

• Review material product specifications to understand the requirements of the components and parts.

• Document non-conformance report once parts fail specifications or requirements.

• Read and understand certification of conformance and certification of analysis.

• Records inspection and test data as prescribed by written instructions and procedures.

• Work may require collaboration with other Abbott divisions.

• Recommend improvements to the production process to ensure quality control.

• Responsible for completing documentation in a timely manner and in accordance with business standards.

• Foster the production team about quality control concerns to improve quality of the product.

• Maintain quality documentation in accordance with SOPs, WIs and GMP (CFRs).

• Resolve quality-related issues in a timely manner.

• Perform audits of manufacturing records during assembly to ensure compliance.

• Support engineering with other documentation related tasks as required.

• Provide Quality support to key processes and product development/improvement projects.

• Adhere to Good Manufacturing Practices and Good Documentation Practices.

• Possess a basic understanding of the Quality System; including the Subsystems and is familiar with the Quality System Key processes.

• Suggests to manager and implements process improvements within own work that fosters a culture of continuous improvement.

• Support other functional areas as needed.

• Keep abreast of the standards that regulate our industry.

• Other tasks and duties as assigned.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• High school diploma or equivalent qualification.

• Excellent knowledge of MS Office and Excel.

• Good math and technical skills.

• Strong understanding of quality control standards and testing techniques.

• Must have a minimum of 5 years’ experience working in inspection, or related field.

• Comfortable in a Cleanroom environment.

• Positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.

• Multitasks, prioritizes and meets deadlines in timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Ability to maintain regular and predictable attendance.

• Very high level of attention to detail and accuracy.

• Excellent verbal and written communication skills.

• Ability to collaborate effectively.

• Must be an effective team player with the ability to train other technicians.

• Confident and open personality who can communicate effectively, both written and orally with people at all levels.

• Ability to work efficiently under tight timelines.

Preferred

• 5+ years prior medical device experience preferred.

Apply Now

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

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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