Quality Assurance Specialist

4 weeks ago

Santa Clara, California, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories 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.

Job Summary

We are seeking a Quality Technician to join our Structural Heart Division team in Santa Clara, CA. As a Quality Technician, you will support manufacturing in the Structure Heart Division of Abbott, reporting to the Manager of Quality.

Key Responsibilities
  • Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions
  • Responsible for performing in-process and final components, subassembly, and product inspection
  • Measure component dimensions per requirements or inspection plans
  • Records inspection and test data as prescribed by written instructions and procedures
  • Understand the capability of measuring tools and utilize small hand-tools, calibrated instruments, measuring equipment, microscopes, and test fixtures
  • Understand material product specifications, engineering drawings, and the requirements of the components and parts
  • Document non-conformance report once parts fail specifications or requirements
  • 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
  • Perform final manufacturing Device History Record (DHR) and Lot History Record (LHR) review at close of manufacturing process and product release
  • Take appropriate action per procedural requirements and schedule when identify any potential nonconformance
  • 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
  • Possesses a basic understanding of the Quality System, including Subsystems, and is familiar with the Quality System Key processes
  • Adheres to a culture of continuous improvement
  • Supports engineering with documentation-related tasks as required
  • Supports trending process and maintains Quality Records
  • Provide Quality support to key processes and product development/improvement projects
  • Adheres to Good Manufacturing Practices and Good Documentation Practices
  • Supports receiving inspection activities, including but not limited to inspection and gathering all defined requirements and documentation to release parts/components
  • Supports Equipment Controls and calibration/PM activities, including coordination with Calibration house, update Equipment log
  • Keeps abreast of the standards that regulate our industry
  • Support other functional areas as needed
Requirements
  • High school diploma or equivalent qualification
  • 4+ years' experience working in manufacturing or a related field
  • Excellent knowledge of MS Office and Excel
  • Good math and technical skills
  • Strong understanding of quality control standards and testing techniques
  • Positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors
  • Knowledge of Quality Systems, FDA regulations, ISO 13485, and applicable worldwide regulator requirements
  • Multitasks, prioritizes, and meets deadlines in a 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
Preferred Qualifications
  • 3+ years prior medical device experience preferred

Abbott is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary and benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits.

Apply now to join our team and take the first step towards a rewarding career with Abbott Laboratories.

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