Quality Assurance Technician III

Job description

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 107,000 colleagues serve people in more than 160 countries

     

JOB DESCRIPTION:

Structural Heart (SH)  Structural heart disease encompasses a range of conditions, from acquired valvular disease to congenital defects of the valves or other heart structures. And we’re at the forefront of transforming structural heart therapies, leading the development of more advanced solutions for patient care. 

The Cephea Mitral Valve System is intended to replace the native mitral valve using a percutaneous, transseptal procedure.  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 Quality Technician III, you will support manufacturing in the Structure Heart Division of Abbott, reporting to the Manager of Quality.

CORE JOB RESPONSIBILITIES

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

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Responsible for performing in-process and final components, subassembly and product inspection.

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Measure component dimensions per requirements or inspection plans.

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

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

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Understand material product specifications, engineering drawings and the requirements of the components and parts.

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

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Recommend improvements to the production process to ensure quality control

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

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

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

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Resolve quality-related issues in a timely manner.

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Perform audits of manufacturing records during assembly to ensure compliance.

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Perform final manufacturing Device History Record (DHR) and Lot History Record (LHR) review at close of manufacturing process and product release

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Take appropriate action per procedural requirements and schedule when identify any potential nonconformance.

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Work with engineers and manufacturing to transfer technical information into easy to understand written form, as well as take a hands-on approach to learning and documenting the processes.

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Possesses a basic understanding of the Quality System, including Subsystems and is familiar with the Quality System Key processes.

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Adheres to a culture of continuous improvement.

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Supports engineering with documentation related tasks as required.

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Supports trending process and maintains Quality Records.

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

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Adheres to Good Manufacturing Practices and Good Documentation Practices.

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

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Supports Equipment Controls and calibration/PM activities including coordination with Calibration house, update Equipment log

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Keeps abreast of the standards that regulate our industry.

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Support other functional area as needed.

QUALIFICATIONS and SKILLS

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High school diploma or equivalent qualification.

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Excellent knowledge of MS Office and Excel

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Good math and technical skills.

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Strong understanding of quality control standards and testing techniques.

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4+ years’ experience working in manufacturing, or related field

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3+ years prior medical device experience preferred

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

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

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Multitasks, prioritizes and meets deadlines in timely manner

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

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Ability to maintain regular and predictable attendance

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Very high level of attention to detail and accuracy

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Excellent verbal and written communication skills.

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Ability to collaborate effectively.

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

WHAT WE OFFER:   
 

At Abbott, you can have a good job that can grow into a great career. We offer: 

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Training and career development , with on-boarding programs for new employees and tuition assistance  

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Financial security through competitive compensation, incentives and retirement plans  

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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs 

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Paid time off   

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401(k) retirement savings with a generous company match 

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The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com   

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

     

JOB FAMILY:

Operations Quality

     

DIVISION:

SH Structural Heart

        

LOCATION:

United States > Santa Clara : Building A - SC Floor-1

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

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.

     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf