Quality Assurance Specialist

18 hours ago

Santa Clara, California, United States Abbott Laboratories company Full time
About the Role

Abbott Laboratories is seeking a highly skilled Quality Assurance Specialist to join our Structural Heart Division team in Santa Clara, CA. As a key member of our team, you will be responsible for conducting functional testing, receiving inspection activities, and ensuring the quality of our medical devices.

Key Responsibilities
  • 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.
  • Responsible for the inspection of components/materials, information for use (IFUs), packaging, and labeling materials.
  • Responsible for performing in-process and final components, sub-assembly and product inspection.
  • Measure component dimensions per requirements or inspection plans.
  • 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.
  • Responsible for Inventory Control including material transfer activities, maintain inventory and inventory logs.
  • Records inspection and test data as prescribed by written instructions and procedures.
  • Support Equipment Controls and calibration/PM activities including coordination with Calibration house, update Equipment log.
  • 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.
  • Perform final manufacturing Device History Record (DHR) review at close of manufacturing process and product release.
  • Support engineering with other documentation related tasks as required.
  • Supports trending process and maintains Quality Records.
  • 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 area as needed.
  • Keep abreast of the standards that regulate our industry.
  • 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.
  • Ensure storage of samples and documents in the appropriate filling systems.
  • Perform audits of manufacturing records during assembly to ensure compliance.
  • Perform final manufacturing Device History Record (DHR) review at close of manufacturing process and product release.
  • Support engineering with other documentation related tasks as required.
  • Travel up to 10% of the time as necessary to support organizational goals.
  • Other tasks and duties as assigned.
Requirements
  • 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.
  • 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 Qualifications
  • 5+ years prior medical device experience preferred.

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