8 days old

QA Specialist

Abbott
Santa Clara, CA 95050

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 103,000 colleagues serve people in more than 160 countries.

CORE JOB RESPONSIBILITIES

  • Responsible for maintaining Non-Conformance log.
  • Responsible to hold MRB.
  • Drive the closure of non-conformance reports.
  • Responsible for Inventory Control including material transfer activities, maintain inventory and inventory logs.
  • Responsible for Equipment Controls and Calibration/PM activities including coordination with Calibration house, update Equipment log
  • Prepare and submit documentation changes per the Change Order approval process in Quality System.
  • Help department to coordinate training to operating procedure changes or new system implementation.
  • Work with engineers to create memos to file, and other engineering documents as needed.
  • 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.
  • Support solving internal/supplier correction and corrective and preventive actions.
  • Support quality management systems operation within organization.
  • Directly writing and reviewing SOP, WI to ensure compliance, efficiency and clarity.
  • Recommend, implement and direct others to modify operational methods and practices along with overall strategy to enhance department effectiveness.
  • Understand and comply with applicable policies, procedures and guidelines.
  • Collaborate with other Abbott divisions.
  • Other tasks and duties as assigned.

    EDUCATION / QUALIFICATIONS / SKILLS

    • Bachelor's degree or equivalent experience and demonstrated competence.
    • Must have a minimum of 0-5+ years’ experience working in inspection, or related field
    • Medical device experience preferred
    • Excellent knowledge of MS Office and Excel
    • Good math and technical skills.
    • Strong understanding of quality control standards and testing techniques.
    • 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.","title":"QA SpecialistDivision: SH Structural Heart
      Travel: Yes, 10 % of the Time
      Medical Surveillance: Yes
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Posted: 2019-12-04 Expires: 2020-01-03

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QA Specialist

Abbott
Santa Clara, CA 95050

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